Quality Assurance Manager

Job Duties and Responsibilities:

The QA Manager will keep abreast of guidance released by the FDA/EMA and other relevant regulatory bodies to ensure that Quality Assurance and related activities throughout the facility comply and continuously improve. The QA Manager will ensure that the facility is operating to support production and product release.

The position involves the following activities:

• Release batch records for clinical trials and the commercial market

• Write and update relevant SOPs

• Investigate exceptions

• Manage change controls

• Manage packaging and control lines in production processes.

• Conduct self-inspections

• Write documents such as risk surveys, annual reviews, work procedures, etc.

• Prepare quarterly and annual quality reports

• Collaborate with production, maintenance, laboratories, R&D, etc.

Requirements:

• Education: MSc/ BSc in Pharmacy preferable, Chemistry /Biology /Biotechnology degree

• Candidate should have at least 3 years of experience in a similar position

• Experience in QA in the biotech/pharmaceutical industry (GDP or GMP environment required) – a must

• Background and work experience with the FDA and/or EMA – an advantage

• Fluent in English (speaking, reading, and communicating effectively).

• The job requires a candidate with a scientific mindset, high work ethics, professionalism, the ability to work under pressure within tight timelines, as well as excellent attention to detail and organizational skills.