QA Validation Manager
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Accentuate Staffing is partnering with a global pharmaceutical company who is hiring for a QA Validation Manager. This is a direct hire opportunity, offering competitive pay and benefits, working onsite. The ideal candidate will be a Validation subject mater expert, managing the day to day activities conducted by the Validation department, providing leadership on the activities of the internal validation staff as well as external validation contractors.
Responsibilities:
- Leads the Validation Team to provide excellent service to customers and ensure compliance to cGMP and FDA/EMEA regulations.
- Managing the development and the execution of all qualifications, validations, re-qualifications and re-validations for process and laboratory equipment, computer systems, utilities, facilities, manufacturing and cleaning processes.
- Performing and documenting risk assessments of systems and processes, assessing change proposals, drafting/reviewing/approving protocols and reports, evaluating deviations/change controls and initiating revisions of GMP documentation related to validation.
- Serving as the Validation subject matter expert, track and report action plan status/ completion as it relates to validation systems improvement efforts.
Requirements:
- BS degree in engineering or a related scientific field.
- Ten years of validation experience within a pharmaceutical environment.
- Eight years of supervisory experience.
- Demonstrated experience with the following: validation life cycle, validation protocols (IQ/OQ/PQ) generation and execution of manufacturing and laboratory equipment, clean process utilities, classified facilities, cleaning and process validations.
- Thorough knowledge of the of steam sterilization, cleaning and process validation and equipment qualification.
