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Über
Excellent employment opportunity for a QA Interim Manager in the Fremont, CA area. Plan and manage the work of the Quality Assurance group overseeing Quality Control Provide technical expertise on Quality Assurance standards Identify deviations from SOPs in Quality Control operations; records and reports issues to appropriate parties; recommends corrective action and follows up to ensure resolution. Supports QA Disposition by review and approval of QC disposition elements (test record reviews, CofA approval, CofC, EM assessments etc.) Review and approval of QC Standard Operating Procedures and Change Controls to ensure compliance with cGMP requirements. Review and approval of method transfers, method qualifications and QC protocols. Oversight and approval of OOX investigations. Support Data Integrity initiatives at the site. Proposes and executes process and procedural changes to improve QA process performance, robustness, and efficiency. This may include any of the quality systems within the plant (for example: Document Review, Deviations, CAPA, Change Management, Training, Lot Disposition). Understanding and appreciation for regulatory requirements and quality and compliance standards under which the Fremont site is operating. Key functions are Manufacturing, E&T, Process Science, and Quality. Exposure to and dialogue with various colleagues and customers within company, particularly in the quality and manufacturing functions. Experience:
Requires a Bachelors degree with plus 5 years Quality experience in a cGMP pharmaceutical manufacturing environment with positions of progressive responsibility with a minimum of 3 years experience managing/directing people. Demonstrates ability to execute against the strategic and tactical objectives provided by senior leaders both within Quality and outside of the function. Overall understanding of Quality Assurance specifications and process In-depth understanding of QC/Pharma Business Strong team leadership skills Ability to communicate in an open, customer-focused manner. Proficiency with MS Office products (specifically Word, Outlook, Powerpoint and Excel).
Sprachkenntnisse
- English
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