Total 5 pharmacist job vacancies in Quality Assurance / Control category in Malaysia

Job Description

The Quality Assurance Release Pharmacist will have responsibility to ensure all products are released for sale according to Good Manufacturing Practice (GMP) requirements and within set timelines. 

The position ensures quality standards, processes and specifications are in line with registered information and global GMP requirements.

Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements.  Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network dedicated to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

Primary Responsibilities:

• Management and oversight of the release of all finished, packaged product to the market.

• Management and oversight of the release of bulk product for primary and secondary product packaging.

• Management and oversight of the release of fully packaged & imported products.

• Implementation of and adherence to our Company's global and Health Authority requirements for batch disposition.

• Participation in deviation classifications and investigations, Quality Risk Management and Change Control Systems.

• Participation in Health Authority and Global quality audits.

• Participate in and lead [as required] meetings, problem solving sessions and strategy development plans with company representatives for which our Company operates as a Contract Manufacturing Organization.

• Management of retention samples.

• Ensuring that bulk and product are released on time as per the Company's scheduled release dates.

• Collaborating with the Quality Control lab, warehouse, production teams to ensure release of bulk and product on time as per the Company's set release dates.

• In-market quality responsibilities for products at our third-party logistics (3PL) distributors.

Education:

• Degree in Pharmacy

Experience:

• Minimum of 1-3 years managing product releases end to end in the pharmaceutical industry.

• Experience in the Quality Assurance pillar.

• Experience in Good Manufacturing Practices

• A good understanding of SAHPRA GMP requirements.

• A good understanding of Market Authorization Holder requirements

• Experience in SAP

Skills:

• Effective Collaboration skills

• A high degree of accuracy is required to ensure compliance with the Company's quality systems.

• Effective communication skills [written and verbal]

• Proactive

• Agility

• Results driven.

Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of biopharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that’s devoted to delivering a high quality, reliable supply to customers and patients on time, every time. 

Current Employees apply HERE

Current Contingent Workers apply HERE

Search Firm Representatives Please Read Carefully 
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.  No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 

Employee Status:

Regular

Relocation:

No relocation

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Job Scope:

• Perform the role of Lead Investigator into incidents to which you have been assigned. In doing so, it is necessary to immediately:
  • Visit the area where the incident has been detected (if applicable, e.g. if detected internally in an operational setting)
  • Discuss with all involved in the incident to gain a full understanding of the process and incident per GQA.003
  • Gather background information (or coordinate accordingly) regarding the reported incident
• Perform an initial impact assessment in a timely manner. Identify immediate action to be taken in order to ‘ring-fence’ the problem and ensure it is not further exacerbated whilst the investigation is ongoing.
• Liaise with personnel within various departments / sites and encourage individuals to be forthcoming with pertinent information to facilitate the investigation. This may involve Lead Investigators in other areas or at other sites.
• Host internal meetings (locally or globally, as applicable) and co-ordinate brain-storming sessions to advance the investigation.
• Use appropriate Root Cause Analysis tools (as applicable) to establish causes and any contributory factors.
• Determine the communication strategy and effectively liaise with the PL /PM (as applicable) and all other relevant parties to appraise them of the investigation as it progresses (where applicable). This may extend to include notification of customers, VPs, Key Account sponsors, BD, Commercial Contracts, Quality Management and the QPs (as applicable).
• Escalate to department manager and Quality management any critical issues that become apparent during the course of the investigation that may not have been immediately obvious.
• Determine appropriate and meaningful CAPA to prevent recurrence. Gain agreement of such with department managers (locally or globally, as applicable).
• Document the investigation in the appropriate template. Ensure the report is written to a high standard and that every effort is made to ensure it is Right First Time and acceptable to the customer and the regulators.
• Proactively monitor the progress of all investigations assigned to you and prioritise accordingly. Take responsibility and ownership for such endeavoring to ensure close out in a timely manner. Escalate any that are overdue.
• Perform CAPA effectiveness checks as required in a timely manner and provide the necessary evidence of such to Quality.
• Host or participate (as applicable) in external teleconferences / meetings / regulatory inspections to discuss particular incidents, should additional explanation or assurance be needed. Ensure all such contact, oral and written, is carried out professionally in order to develop and maintain good relationships.
• Promote good inter-departmental and global relationships. Work within and across functions and sites as necessary to assure global consideration of investigations and the CAPA arising from such.
• Endeavor to approach problems with a positive attitude and as an opportunity for company to continuously improve.
• Attend all necessary training and retain a thorough knowledge of processes / procedures pertinent to the area you represent.
• Update KPIs and capture trending information at a department level, ensuring there is good visibility of this data globally. Remain observant of recurring issues, taking such into consideration at the point of an investigation and escalate to management as applicable.
• Meet regularly with management to discuss KPI and trending data. Present ideas / suggestions for consideration into further process improvements.
• Attend periodic meetings with other Lead Investigators locally and globally. Be forthcoming with ideas / experiences to ensure shared learning and continuous improvement.
• Ensure documentation is generated and completed in accordance with the principles of GMP and internal SOPs.
• Fulfil any necessary duties associated with the role, as and when required.

Requirement

• Min. Degree in Science or other equivalent
• Has prior QA background with focus on report generation and reviews
• Able to engage multiple stakeholders independently.
• Has prior pharma background will be an advantage

If interested, please email your resume to alexgoh@recruitexpress.com.sg
➖
Alex Goh Hock Leong
(CEI.No: R1763413 l Recruit Express Pte Ltd (Healthcare & Life Science) | 99C4599)

Job Scope:

• Perform the role of Lead Investigator into incidents to which you have been assigned. In doing so, it is necessary to immediately:
  • Visit the area where the incident has been detected (if applicable, e.g. if detected internally in an operational setting)
  • Discuss with all involved in the incident to gain a full understanding of the process and incident per GQA.003
  • Gather background information (or coordinate accordingly) regarding the reported incident
• Perform an initial impact assessment in a timely manner. Identify immediate action to be taken in order to ‘ring-fence’ the problem and ensure it is not further exacerbated whilst the investigation is ongoing.
• Liaise with personnel within various departments / sites and encourage individuals to be forthcoming with pertinent information to facilitate the investigation. This may involve Lead Investigators in other areas or at other sites.
• Host internal meetings (locally or globally, as applicable) and co-ordinate brain-storming sessions to advance the investigation.
• Use appropriate Root Cause Analysis tools (as applicable) to establish causes and any contributory factors.
• Determine the communication strategy and effectively liaise with the PL /PM (as applicable) and all other relevant parties to appraise them of the investigation as it progresses (where applicable). This may extend to include notification of customers, VPs, Key Account sponsors, BD, Commercial Contracts, Quality Management and the QPs (as applicable).
• Escalate to department manager and Quality management any critical issues that become apparent during the course of the investigation that may not have been immediately obvious.
• Determine appropriate and meaningful CAPA to prevent recurrence. Gain agreement of such with department managers (locally or globally, as applicable).
• Document the investigation in the appropriate template. Ensure the report is written to a high standard and that every effort is made to ensure it is Right First Time and acceptable to the customer and the regulators.
• Proactively monitor the progress of all investigations assigned to you and prioritise accordingly. Take responsibility and ownership for such endeavoring to ensure close out in a timely manner. Escalate any that are overdue.
• Perform CAPA effectiveness checks as required in a timely manner and provide the necessary evidence of such to Quality.
• Host or participate (as applicable) in external teleconferences / meetings / regulatory inspections to discuss particular incidents, should additional explanation or assurance be needed. Ensure all such contact, oral and written, is carried out professionally in order to develop and maintain good relationships.
• Promote good inter-departmental and global relationships. Work within and across functions and sites as necessary to assure global consideration of investigations and the CAPA arising from such.
• Endeavor to approach problems with a positive attitude and as an opportunity for company to continuously improve.
• Attend all necessary training and retain a thorough knowledge of processes / procedures pertinent to the area you represent.
• Update KPIs and capture trending information at a department level, ensuring there is good visibility of this data globally. Remain observant of recurring issues, taking such into consideration at the point of an investigation and escalate to management as applicable.
• Meet regularly with management to discuss KPI and trending data. Present ideas / suggestions for consideration into further process improvements.
• Attend periodic meetings with other Lead Investigators locally and globally. Be forthcoming with ideas / experiences to ensure shared learning and continuous improvement.
• Ensure documentation is generated and completed in accordance with the principles of GMP and internal SOPs.
• Fulfil any necessary duties associated with the role, as and when required.

Requirement

• Has prior QA background with focus on report generation and reviews
• Able to engage multiple stakeholders independently.
• Min. Degree in Science
• Has prior pharma background will be an advantage

If interested, please email your resume to alexgoh@recruitexpress.com.sg
➖
Alex Goh Hock Leong
(CEI.No: R1763413 l Recruit Express Pte Ltd (Healthcare & Life Science) | 99C4599)

Join a leading pharmaceutical company and make a real difference in people's lives.

As a Quality Release Pharmacist, you will play a vital role in ensuring the quality of the companies products.

You will be responsible for maintaining the QPL licences and authorities, leading and closing audits, monitoring quality KPIs, and promoting a culture of continuous quality improvement. You will also be responsible for educating colleagues in GMP and GDP, acting as Quality authorisation, and developing a strategy for the Quality Department.

To be successful in this role, you will have a Master's Degree in Pharmacy, be a UK registered pharmacist, and have at least 6 months experience in the pharmaceutical industry. You will also have GMP knowledge and experience, strong literacy, written and numerical skills, good IT skills, and be a keen team player.

On offer is a competitive salary, generous holidays, free fruit, bread and jams onsite, eye care vouchers, and an active social and charity committee.

If you are a passionate, honest, and agile individual who is looking to make a real difference in people's lives, then we would love to hear from you.

Carbon60, Lorien & SRG - The Impellam Group STEM Portfolio are acting as an Employment Business in relation to this vacancy.

Major duties include but are not limited to:

Data Management

• Produces reports to CMOP management, local committees, host sites, and the National CMOP Program to support exceptional organizational performance. Uses basic quality and analytical techniques to process internal and external data and make recommendations for improvement.
• Develops and maintains a basic knowledge of databases and the pertinent CMOP local and central databases.
• Works with established systems to effectively extract, analyze, store, and trend data and provide reports to management in a timely manner.

Patient Safety

• Assists in investigation of errors reported through the National CMOP Web Application, telephone reports from host sites, and internal error reporting systems.
• Uses established systems for monitoring internal and external error data for trends. Upon discovery, immediately reports to the Director through appropriate supervisory channels, any issues posing significant or imminent risks to patient safety.
• Assist in preparing local, national quality assurance reports on a scheduled or ad hoc basis. Produces reports for CMOP management which provides identification of trends to optimize medication dispensing safety.

Automation Support

• Stays current regarding new pharmacy automated dispensing technology.
• Monitors performance of the automated dispensing equipment, communicates issues, progress and status to Supervisory Pharmacist to ensure optimal performance, safety, and workflow.
• Provides leadership and guidance to individuals working with the automated processing equipment, including establishing guidelines for performance, reviewing accuracy, quality and efficiency of general workflow.
• Assists in developing policies, procedures, and training guidelines for the proper use and maintenance of automated dispensing systems.

Accreditation/ Regulatory Compliance

• Effectively interacts with accreditation and regulatory officials and reports data as required.
• utilizes established data management tools to ensure continuous survey readiness.
• Supports continuous survey readiness activities, including but not limited to: supporting alignment of local survey readiness with the national CMOP program, maintaining a working knowledge of The Joint Commission (TJC) standards which impact CMOP, and assisting in completion of all accreditation process requirements in a timely manner.
• Effectively communicates with management and participates in development and implementation of appropriate organizational responses when indicated by current performance or changes in standards or regulations.

Inventory/Product Line Support/Liaison

• Stays current regarding new pharmaceutical therapies, developing standards of pharmacy practice and advances in information technology.
• Identifies opportunities for increased dispensing efficiency related to product movement, viable pack sizes, re-distribution among systems and sub-systems and makes recommendations to the Supervisory Pharmacist or Logistics Manager.
• Provides quality assurance guidance for replenishment activities of pharmacy technicians regarding automated dispensing equipment.
• Participates in coordination of inventory management/procurement in an effort to meet CMOP initiatives.
• Reviews backorder report and takes action to ensure timely processing
• Prepares CMOP shortage report for internal and external use.

Administrative/Program Support

• Performs the full range of Clinical Pharmacist (Production) duties as needed.
• Assists in developing and maintaining local policies, procedures, and training tools to ensure compliance with current standards and regulations.
• Develops and communicates understanding of laws, regulations, accreditation standards related to the distribution and control of scheduled and non-scheduled drugs and pharmacy security.

Work Schedule: Monday through Friday, 3:30pm to 12:00am CST
Telework: Not Available
Virtual: This is not a virtual position.
Functional Statement #: QA Pharmacist/70070AA
Relocation/Recruitment Incentives: Not Authorized
Permanent Change of Station (PCS): Not Authorized
Financial Disclosure Report: Not Required

Starting at $89,848 Per Year (GS 12)