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QA Validation Specialist
3 months ago
Quality Assurance Validation Specialist
Millburn, New Jersey
1 year contract with likelihood of extension
Project Goal & Overview:
Novartis is seeking a seasoned QA (Quality Assurance) Validation Specialist to support the strategic implementation of quality and validation objectives. This individual will play a critical role in ensuring that all pharmaceutical products meet rigorous quality standards and regulatory requirements, contributing to the safe and effective delivery of products to patients. We are looking for this person to be a strategic thinker, great team player, and a true problem solver.
Deliverables/Milestones:
- 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.
- Contribute to the generation of the Annual Product Reviews.
- Primary SME for the GMP regulatory inspections, specifically for qualification and validation matters. o Ensure the coaching and training of the quality team and other associates within the Production and QC in qualification and validation field.
Qualifications:
- Bachelor’s degree in Biology, Chemistry, Engineering, or a related scientific field required.
- 5 years of experience in Pharmaceutical Manufacturing, at least 3 years combined of relevant experience in QA Validation role.
- Minimum 3-5 years of experience with Computerized System Validation (CSV), Equipment Validation, and/or Process Validation required.
- 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.
- 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
