Responsibilities: Responsible for providing quality oversight for the qualification and validation activities for equipment, utilities, and facilities.
This role will be responsible for drafting, reviewing and approving qualification protocols/reports and any associated documentation in support of CQV activities for a new facility.
The Role also needs to drive the validation activity close out.
Assist in development, review, and approval of cGMP documents including, but not limited to: Master Validation Plans, FAT/SAT documents, Turnover Packages, SOP's, specifications, traceability matrices, thermal mapping documents, and design documentation.
Provide expertise and solutions to issues regarding CQV Lifecycle documentation in regards for applicable FDA/EMEA Regulations.
Support validation activities for project activities including review of validation documentation (FAT, SAT, URS, SDS, IQ, OQ, PQ) and attendance at validation activities.
Provide support to enforce CQV guidelines, policies and procedures for equipment, analytical equipment, utilities, and facilities (Examples: Bioreactor, Incubator Chromatography Systems, harvest hold tank, washers, autoclaves, etc.)
Focus of this role will be to Qualify Clean Rooms.
Employee will be required to work closely with Manufacturing, Validation, Site Automation, Engineer, Quality Control, and Global Technical Operations (GTS) associates.
Ensuring appropriate investigation of validation discrepancies, errors, protocol failures, or validation testing errors requiring documented review and action to reconcile deviations.
Requirements: Minimum of 9+ years' experience in validation, biological quality assurance and/or quality control in an FDA-regulated biotechnology or pharmaceutical company with progressive levels of responsibility.
1-3 years in a quality assurance or quality control role in an FDA-regulated company.
Past experience with balance reports, hepa filter certs, and all associated utilities and equipment.
Strong knowledge of cGMP's 21CFR parts 2010 & 211, knowledge of 21CFR600 – Biologics desirable.
Demonstrated knowledge of ISPE Baseline Guide 5, ASTM E-2500, EU regulatory requirements, and GAMP 5 Validation Lifecycle.
Knowledgeable in risk assessments and process for following well documented and thought through risk-based approaches.
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