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gmp regulatory sops cmos capa📋 Description
- Manage lot release activities at CMOs as QA Operations lead.
- Review manufacturing batch records, COAs, and certificates of compliance.
- Ensure CMOs' SOPs and Master Batch Records comply with cGMP.
- Lead DS/DP/FP disposition activities.
- Escalate and communicate deficiencies to CMOs for timely resolution.
- Support regulatory filings and audits of CMOs.
🎯 Requirements
- Bachelor’s degree in science with 8+ years in biopharma or CRO.
- Strong knowledge of GMP, SOPs, Quality Systems (Lot Release, Deviation, CAPA), ICH and GxP.
- General knowledge of FDA and global clinical trial regulations.
- Experience in QC, Analytical Development and process validation highly desired.
- Excellent verbal and written communication with strong customer focus.
- Excellent organizational skills with attention to detail.
🎁 Benefits
- Financial Benefits: Market-leading compensation
- Financial Benefits: 401K with match on the first 3% and 50% on the next 2%
- Financial Benefits: Employee stock purchase program
- Health & Wellbeing: Comprehensive health care with premiums covered
- Health & Wellbeing: Hybrid work model with PTO and parental leave
- Skill Development & Career Paths: Career development programs and internal mobility
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