Associate Director

4 weeks ago


Singapore VALERE SG PTE. LTD. Full time
Roles & Responsibilities

Responsibilities

· Responsible for the development and implementation of Quality Control strategy.

· Establishment, review, approve and maintenance of Quality Control standards, procedures, and test specifications.

· Build and manage the QC team to support cGMP operations to perform test procedures to determine the quality, uniformity and stability of raw materials and finished products as per our partners’ requirements, current Good Manufacturing Practices (cGMP’s) and current Good Laboratory Practices (cGLP’s).

· Responsible for establishing Sample Management, Microbiology, Environmental Monitoring, Sterility Lab, Raw Material, Analytical, Biochemistry, Analytical Method Validation, Method Suitability Test, Method Transfer, QC Systems (LIMS, LEQ Support) teams to support ATMPs Quality Control Testing.

· Qualify analytical methods, including compendial methods. Technological transfer from Analytics team to QC team.

· Lead, review, and approval of Quality Events such as Change Controls, deviations / non-conformances, OOS, LIR raised by QC Labs as needed.

· Provide R&D support for the introduction of new raw materials and new product launches.

· QC Lead for audits/inspections by customer and regulatory agencies.

· Ensuring timely release of test results and approval of certificate of analysis to release batches on time.

· Involve in the generation of the Annual Product Reviews.

Requirements

· Master’s in Biotechnology, Bioengineering, Pharmaceutical Sciences, Chemistry, Chemical Engineering or related fields. PhD preferred.

· 5 -10 years of work experience in quality control. Candidates with experience in Biopharma manufacturing preferred.

· Innovative and analytical thinker with outstanding interpersonal, communication, and leadership skills

· Thorough understanding of current regulatory requirement of cGMP biologics and pharmaceutical industries.

· Experience in handling audits in US FDA, EU EMA, TW FDA and SG HSA.

· Good understanding of PIC/s GMP Guides, ICH guidelines and USP.

· Able to multi-task and prioritise work


Tell employers what skills you have

FDA
Quality Control
Analytical Biochemistry
GMP
Microbiology
Raw Materials
Chemistry
Biotechnology
LIMS
Audits
Sample Management
Laboratory
Analytical Method Validation
Manufacturing
Chemical Engineering
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