Sr QA Validation Engineer

3 days ago

Singapore GDMC Full time

**Key **Responsibilities**

Your responsibilities include, but are not limited to:

- This position will support operational readiness of a new facility.
- Establishment of QA Validation procedures (drafting and reviewing QA Validation functional SOPs).
- Act as SME to develop commissioning, validation and qualification procedures, train and guide site personnel in validation area including guidance on audit preparations
- Primary SME for the GMP regulatory inspections, specific to qualification and validation matters.
- Participate and Lead in CQV Risk Assessments.
- Leading CQV discrepancies
- Represents site QA Validation for Facility Equipment and systems, Computerized Systems, Laboratory systems and participate on SOP authoring/review and implementation to site.
- Support establishment, review and approve maintenance plans and calibration strategy, and execution in collaboration with site Manufacturing/Engineering teams.
- Review of deviations / non-conformances and lead the strategic discussion for investigations with respect to CQV matters & manufacturing operations.
- Review and approve CQV documents, changes related to facility, computerized systems/automation, laboratory or products. Ensure proper assessment with respect to Qualification and Validation is conducted.
- Review/approve investigation of operations in manufacturing/laboratory or other related operations.
- Performs QA oversight for Validation and Qualifications activities for Manufacturing, QC studies.
- Support the generation of the Annual Product Reviews.
- Ensure the coaching and training of the quality team and other associates within the Production and QC in qualification and validation field.
- Support Cleanroom Commissioning, Qualification & Validations
- Responsible to identify OOS/OOT/Deviation and participate in Root Cause Analysis (RCA) and recommend corrective and preventive actions as applicable.
- Actively participate in Safety initiatives, and perform investigation related to EHS (as needed).

**Qualifications**
- Minimum a degree or diploma in the scientific field (Biotechnology, Bioengineering, Biopharmaceutical Manufacturing etc.)

**Required Skills/Experience**
- Ability to prioritize work and multitask.
- Thorough knowledge and understanding of current regulatory requirements of GMP Biologics and Pharmaceutical industries.
- Good understanding of PIC/s GMP Guides, ISPE Baseline Guideline Pharmaceutical Guide principles, ASTM E2500-13, 21 CFR Part 11 & EudraLex Annex 11.
- Good knowledge and understanding of Biologics manufacturing, aseptic operations and cleanroom behavior.
- A demonstrated ability to supervise, train, and manage technical staff.
- Demonstrated knowledge in Quality Control operations as it relates to method validations and QC system implementation is an added advantage.
- cGMP regulations and audit experience in USFDA, EU and HSA etc.

**Additional Skills/Experiences**
- Excellent communication, interpersonal and organizational skills.
- Ability to speak and write in English.
- Must be able to work in Singapore.

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