Roles & Responsibilities
Cellvec Pte Ltd is currently looking for an experienced & Passionate QA professional who can fully support our clinical and commercial GMP manufacturing of Cell & Gene Therapy Products.
This role will provide you the opportunity to lead key activities to progress your career, these responsibilities include some of the following:
- Lead a team of QA professionals to manage and oversee all the areas of GMP operations. Always ensure inspection readiness.
- Effectively manage Change controls, Deviations, OOS, QRM, Document management, Trainings, Audits, Batch release, Qualifications & Validations, Business support, Trends & Reports, Annual Product quality review etc
- Supports regulatory and client audits as Quality subject matter expert.
- Provide QA expertise for cGMP documents including, but not limited to, SOPs, batch records, media fill/APS protocols and reports, validations, Qualifications, Environmental monitoring, Risk assessment and specifications.
- Strategize, plan and organise the team's resources to perform operations.
- Plan and develop working knowledge and stakeholder management of the team of Quality professionals.
- Promote the Quality culture on Site through exemplary behaviours.
- Ensures the implementation of adequate training for aseptic gowning, aseptic qualification, practices and QA observations.
- Participates in review of policies and policymaking.
- Ability to communicate quality operations and compliance perspective effectively to senior management.
- Understands and articulates company business strategy. Maintains a broad view of the business recognizes changes and trends in the appropriate area in which the individual operates.
- Responsibility to drive the focus on safety to the QA staff and into functional areas that routinely support CT/GT manufacturing.
- Any other tasks as and when assigned by the Supervisor.
Ideally, we are looking for candidates with these criteria’s:
- Minimum of Degree in Biochemistry/Microbiology/Biotechnology discipline. Master degree and above are preferred.
- A minimum of 10 years’ experience in the pharmaceutical/Biotech industry, preferably in CGT manufacturing and its GMP compliance.
- Demonstrated experience with helping operations to prepare for Regulatory GMP inspection. Experience managing HSA, USFDA, EU & Client audits are preferred.
- Experience in leading internal, External and regulatory audits. Experience formulating the audit responses and CAPA
- In-depth understanding of cGMP regulations and regulatory requirements of Biotech/Cell and gene industry.
- Strong experience, Extensive knowledge and hands-on experiences of handling Sterile pharmaceutical/Biotech manufacturing processes.
- Ability to apply optimal quality assurance standards to promote a business edge.
- Ability to facilitate business activities compatible to international regulatory environment.
- Ability to communicate effectively within the site organization and across the network.
- Good people management skills.
- Good risk management skills.
- Good Analytical thinking skills.
- Hands on experience in Working with Aseptic environments.
- Exposure in handling Quality Management Systems.
- Exposure in ensuring GLP compliance in QC Laboratory.
