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

Please see the attached Job Description and Person Specification applicant pack for further detailed information regarding this role.

We are recruiting for a Quality Control Pharmaceutical Microbiologist who shares our vision to be trusted to provide consistently outstanding care and exemplary service to our patients.

You will be a suitably qualified professional with significant practical experience of pharmaceutical microbiology. Ability to interpret the current standards and guidance applicable to sterile and non-sterile pharmaceutical facilities and ensure that any microbiology testing and monitoring is undertaken in line with the current industry standards in particular the Guide to Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use and the Manufacture of Sterile Medicinal Products.

Lead the microbiology section of Quality Control Department and develop and deliver pharmaceutical and environmental microbiology and other non-clinical microbiological services. Train and develop staff and plan, organise and deliver high quality microbiology service to all internal and external customers of the Quality Control Department.

Our Values are Include, Respect and Improve. It is important that you understand and refer to our values during your recruitment process and beyond!

Main duties of this role include leadership of the microbiology section of the Quality Control Department, interpretation of current standards, writing and updating of standard operating procedures, staff training a development as well as participation in Quality Management Activities as part of delivery of high quality microbiology services to pharmaceutical and other healthcare facilities.

At East and North Hertfordshire NHS Trust, we are proud of the range of general & specialist services we provide & our 6,000 or so dedicated staff ensure our patients get the best care. Our ability to be flexible & innovative in the way in which we work and deliver our services to our catchment has never been more important than it is now.

We run the following hospitals:
• The Lister Hospital, Stevenage
• New Queen Elizabeth II (New QEII), Welwyn Garden City
• Hertford County, Hertford
• Mount Vernon Cancer Centre (MVCC), Northwood

We have ambitious plans to become an outstanding, patient-led Trust where dedicated staff provide high-quality, compassionate care to our patients. We continue to undergo significant transformation; our staff & patients are at the heart of delivering this ambitious agenda.

We understand that finding and starting a new job is an important life decision. If you need reasonable adjustments for a disability, or a life event, such as menopause - so that we can consider your application fairly & to get the best out of you during the selection process, please let us know.

We are committed to a positive work life balance for our employees. Employees are entitled to seek to work flexible working patterns & we are committed to listen and consider all requests. Such requests, of course, have to be made & considered formally, & will need to be balanced against service needs, but our starting point will always be to find ways to support making them happen.

Please see the attached Job Description and Person Specification applicant pack for further detailed information regarding this role.


This advert closes on Monday 6 May 2024

Job Impact & Requirement

The Laboratory Technician II will complete moderately complex analytical and laboratory testing in support of the food safety quality and operational teams. In this role, you will perform routine analysis of product testing and will check and monitor instrumentation performance, conduct tests and document results into databases and communicate test results.

Key Accountabilities

• Conduct routine quantitative and qualitative inspections and laboratory tests on raw materials, in process and final products independently and support more complex trials and experiments under intermediate supervision.
• Perform Environmental Monitoring - in-line swabbing, ATP swabbing and lab analysis
• Prepare medium and apparatus for microbiological analysis (environmental monitoring)
• Prepare samples and coordinate with 3rd Party Laboratory on the external microbiological laboratory testing for FGs, RMs, swab samples and as per customers’ requirements.
• Ensure compliance programs for all individual testing, which includes monitoring adherence to regulations and other procedural food safety compliance.
• Interpret and document results of tests into active databases and communicate results to internal customers as required.
• Run calibration checks, preventive maintenance tasks and simple repair to analytical instrumentation and maintain customer specifications books.
• Help develop food and feed safety, quality and regulatory culture and collaborate cross functionally to build, maintain and improve an effective food safety, quality and regulatory culture.
• Handle moderately complex clerical, administrative, technical or customer support issues under general supervision, while escalating more complex issues to appropriate staff.
• Other duties as assigned

Minimum Qualifications

• Possess technical and analytical skills in Quality Control
• Demonstrate analytical thinking and problem solving skills
• Possess a good sensory skills for product evaluation and troubleshooting
• Demonstrate ability to handle work professionally, independently and efficiently
• Possess attention to details

We are seeking for a QC Specialist to join our team to support our client in Pharceutical Industry. This is a contract role for a year subject to extention as per client's need.

Responsibilities:

• Perform microbiological analysis of raw material, GPT, ID samples according to Standard operating procedures and Test Methods
• Perform EM which includes BSC / HLFH / VLFH sampling, fingertips monitoring, compressed gases /air and water / clean steam sampling in accordance to cGMP procedures when required
• Documentation of results in accordance with cGMP
• Prepare EM trend reports, EM reports for product lot release and trend reports
• Review routine data and logbooks with supervisory audit
• General lab support including housekeeping, equipment maintenance, inventory of supplies, etc
• Problem solving of issues as well as troubleshooting of equipment
• Author or update existing SOPs, Forms and TMs as needed
• Discrepancy Owner or perform assessment of lab related discrepancies
• Involve in new equipment / methods qualification
• Participate internal and external audits and regulatory inspections
• Understanding of basic microbiological principles (bioburden, LAL, plating and counting techniques, etc) and execution of intermediate techniques (DET, AET)
• Perform equipment qualification / maintenance, liaise with external / contract lab / vendor
• Lead the continuous improvement of laboratory procedures and processes to ensure compliance to GMPs
• Comply with all client's Safety, Health & Environmental (SHE) requirements, never put oneself and others at safety & health risks, and report any workplace accidents, near misses and hazards as soon as practicable
• Engage in proactive measures to promote a positive safety culture while ensuring all applicable Safety, Health and Environment requirements are fulfilled in alignment with corporate policy and local legal requirements
• A team player and the willingness to cover other colleagues in continued support of the Micro/EM testing operations.

Requirements:

• Bachelor's Degree (Chemistry, Microbiology, Biochemistry or any Life Science related is preferred)
• Minimum 1 to 3 years' work experience in the pharmaceutical or related industry preferably QC related
• Knowledge of cGMP relevant to the pharmaceutical industry
• Able to determine when to escalate issue
• Ability to organize and plan effectively
• Good team player
• Demonstrate good verbal and written communication skills in English
• Must be comfortable with contract basis role

Job Description:

• Perform all microbiological testing as required by the SOPs, applicable standards and regulatory requirements.
• Update SOP to align with applicable standards and regulatory requirements.
• Ensure lab supplies are available for testing.
• Conduct laboratory investigation on any out of specification for microbiological testing and environmental monitoring results, working with process owner to identify root cause and appropriate corrective/preventive actions to prevent recurrence.
• Supervise the environmental monitoring program and ensure effectiveness
• Ensure validation is performed for equipment and testing method.
• Support audits, change control, product registration and preparation of relevant reports
• Practice Good Laboratory Practices, Good Documentation Practices and 5S.
• Other ad-hoc tasks as assigned by the superior/management from time to time.

Qualification/Experience:

• Degree in Microbiology or Biotechnology
• Relevant working experience in the laboratory, knowledge in ISO13485 will be an added advantage
• Able to multi-task and work with minimal supervision
• Team player with a good working attitude
• Takes pride in self and work, result-oriented and meticulous