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.
Job Requirements: Ensuring appropriate quality assurance processes Manage a quality assurance team Develop software quality assurance plans Support the quality assurance function Manage the quality assurance department and quality personnel Enhancing software quality assurance capabilities Direct quality assurance and compliance functions Execute as per quality assurance programs Directing quality assurance programs and activities Evaluate adequacy of quality assurance standards Develop detailed project quality assurance plans Manage the plant quality assurance function Building quality assurance standards and structure Verify and revise quality assurance standards Performing multiple software quality assurance tasks Writing and updating quality assurance procedures Motivate team of quality assurance representatives Overseeing all quality assurance and training activities Maintain quality assurance operations by following quality assurance policies and procedures; reporting needed changes Implement quality assurance processes for new software