Address
Form of workManagement of the GMP quality assurance oversight of Qualification, Validation, in relation to Facility Equipment, Computerized Systems, Laboratory systems in order to meet ***, AAA and regulatory requirements in Millburn, NJ.
- Represents site QA Validation SPOC (Single Point of Contact) for Facility Equipment and systems, Computerized Systems, Laboratory systems and participate on SOP authoring/review and implementation to site. Approves Validation strategy and plans for the site.
- Act as SME (Subject Matter Experts) to develop validation and qualification procedures, train and guide site personnel in validation area including guidance on audit preparations or leading investigations whenever required
- Support establishment, review and approve maintenance plans and calibration strategy, and execution in collaboration with site Engineering function.
- Review of deviations / non-conformances and lead the strategic discussion for investigations with respect to operations or validation related matters
- Review/approve investigation of operations in manufacturing/laboratory or other related operations. Oversee resolution of quality events, monitor that recurrent events are properly escalated and resolved. Ensure root cause is determined, evaluate impact on product quality, disposition and corrective actions
- Review and approve changes related to facility, computerized systems, laboratory or products. Ensure proper assessment with respect to Qualification and Validation is conducted. Performs QA oversight for Validation and Qualifications activities for Manufacturing, QC studies.
- Perform final review of test data/reports to ensure conformance to the established specifications and standard operating procedures. Act as Responsible Person for the final disposition of products.
- Ensures supplier qualification activities are performed, including audits execution and Quality Agreements preparations.
- Contribute to the generation of the Annual Product Reviews.
- Primary SME for the GMP regulatory inspections, specifically for qualification and validation matters
- Ensure the coaching and training of the quality team and other associates within the Production and QC in qualification and validation field
- Successful and timely completion of Qualification and Validation activities
- Ensures investigations, CAPAs are completed in a timely /compliant manner
- No critical observation from Health Authorities and Corporate auditing
- 5 years of experience in Pharmaceutical Manufacturing, at least 3 years combined of relevant experience in QA Validation role.
- Proven track record and practical experience in establishing and maintaining quality systems, in facility changes and validation as well as successfully managing authority inspections from major HA's, e.g., USA, EMEA, Canada, Japan, Brazil
- In-depth knowledge of cGMP's, especially FDA regulations 21 CFR Parts 11 for computerized systems
- Strong organizational and time management skills.
- Quality oriented with attention to details.
Highly proactive, self-motivated, professional and dedicated.
MSc in Life Sciences and/or related experience
