Manager – Quality Control (Pharma Plant)
Work Location: Ha Noi
Job type: Full-Time
The Manager – Quality Control will be responsible for all testing from raw materials to intermediate, final and stability product samples to demonstrate that all products meet standards required for GMP operations. The Manager will lead the QC lab to support all analytical needs and ensure GMP compliance. In addition, this role will own and review quality records, processes and documents, including method development, method validation, CAPAs, Change Controls and SoPs.
Tasks and responsibilities:
1. Lab monitoring:
· Manage QC Lab, method validation, equipment and data systems, ensuring that the best practice is promoted.
· Review and approve Certificate of Analysis, Certificate of Test, and stability studies. Further interpret quality control requirements or recommend quality control standards and procedures.
· Undertake the role of Releasing Officer to release or reject each batches of material or product processed within the plant.
· Ensure that stability data is established and stability data files are maintained to support shelf lives and storage conditions assigned to each product.
2. QC process and method management:
· Create, revise, review and approve protocols, supporting analytical data, and reports associated with method validation, testing, and release of materials, intermediates, and final products.
· Approve, monitor and review test methods for both chemical and microbiological testing, including responsibility for negotiating and managing technical agreements with contract laboratories.
· Demonstrate technical proficiency in analytical methodology and adherence to GMP requirements.
· Manage the maintenance and further development of microbiological, physical and chemical monitoring programs for all production and storage environments, equipment, processes.
3. QC services:
· Serve as QC lead on analytical projects teams and product operational teams.
· Collaborate with regulatory to support the fulfillment of regulatory documents and production license.
· Evaluate resource requirements to support projects and assure projects remain within budget.
4. People management:
· Train direct reports on QC job related functions and technical methods.
· Establish and review training curricula for the QC department to develop a comprehensive QC laboratory training plan.
The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Direct Manager from time to time.
· BS or MS in Pharmaceutical Sciences as ideally or Chemistry, Life Sciences or equivalent with at least 8 years of relevant experience in QC or equivalent experience in the pharmaceutical industry.
· 5 to 8 years of relevant GMP QC laboratory experience and at least 3 years in a supervisory role, particularly in a GMP environment.
· Experience in a pharmaceutical manufacturing environment is an advantage.
· Expertise in analytical method development, analytical method validation, and statistical quality control.
· Excellent knowledge of GMP, and as a plus ISO
· Excellent verbal and written communication skills, experience with scientific technical writing including authoring and revising SOP's or technical reports
· Strong leadership skills.
· Able to interact, cooperate, and motivate across departments and functions.
· Work in a fast paced pharmaceutical environment, able to work flexible schedules on a short quick notice.