Katalyst Healthcares and Life Sciences
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.).
- Main 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.
- 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.
- Manufacturing, Validation, Site Automation, Engineer, Quality Control, and Global Technical Operations (GTS) associates.