Quality Assurance Manager
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POST DATE 9/11/2016
END DATE 1/15/2017
Catalent Pharma Solutions, Inc.
Kansas City, MO
JOB DESCRIPTIONUnder general supervision, performs work that is varied and that may be somewhat difficult in character, but usually involves limited responsibility. Some evaluation, originality or ingenuity is required. Follows established protocols and work plans. May be assisted by laboratory technicians / assistants. Comply with divisional and site Environmental Health and Safety requirements.
Daily supervision of quality assurance associates includes direction of daily activities as necessary, resolution of issues with quality assurance and internal, external clients.
Prepare associates performance reviews for assigned associates. Provide performance reviews in both oral and written form to associates.
Review and release of batch documentation.
Review and approval of quality events such as deviations, investigations, document control and change control.
Quality assurance review and approval of validation documents (IQ/OQ/PQ).
Quality assurance review of construction/facilities maintenance activities plans.
Author quality assurance SOPs.
Identify deviations/investigations during manufacturing or packaging process and provide direction as to appropriate course of action.
Lead or assist in GMP training of associates.
Train new associates as required.
Perform packaging audits.
Meet deadlines according to agreed timeframes and communicate adjustments as needed.
Clear understanding of related SOPs, cGMPs necessary to accomplish daily tasks.
Mentor and develop direct reports.
Adhere to company policies.
Attend assigned meetings.