Microbiology Supervisor (QC/ Pharma/ GMP/ GDP)

Microbiology Supervisor (QC/ Pharma/ GMP/ GDP)

Industry: Pharmaceutical

Responsibilities:

• Responsible for the day-to-day operations of the microbiology laboratory and compliance of QC activities with company's standards and policies, GMP, GDP and regulatory requirements.
• Lead the microbiology section within QC to implement appropriate QC systems, from evaluation and selection of lab equipment to purchase.
• Lead and drive the equipment qualification activities, ensuring required consumables/reagents are purchased timely and the equipment installation and qualification activities are done as per projects milestones
• Develop, improve, and maintain microbiological test methods. Identify opportunities, evaluate, initiate, monitor, and conclude operational excellence initiatives in the Microbiological test procedures and processes used at site.
• Perform product testing, environmental monitoring, water testing as required.
• Perform Laboratory Investigation and deviations. Lead and oversee investigations related to all matters of testing related to microbiological topic not limited to product testing, environmental monitoring and water testing
• Participate in regulatory inspection and contract laboratory inspection as an SME during audits/inspections.
• Ensure safe working in the laboratory by practicing and communicating safety.
• Other responsibilities that are not included in the above but are related to quality control and in accordance to internal guidelines and SOP.

• Responsible for laboratory action plans that support site KPI
• Collaboration with Quality Control Manager in capacity, investment, and cost planning.

Requirements:

• 3 years of experience in leading the microbiology laboratory in pharmaceutical or related industries. Be able to adopt hands-on troubleshooting style.
• Good stakeholder and organizational skills
• Sound knowledge in Microbiology and good knowledge for health authorities' regulations (USP, ISO, Eudralex and ICH) and cGMP.
• A degree in microbiology or any other related scientific discipline; with more than 3 years working experiences in supervisory role.

EA Licence: 02C3423

Apple, Pey Chyi Lim EA License No.: 02C3423 Personnel Registration No.: R2090579

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