Amneal Pharmaceuticals, Inc. is a global pharmaceutical company. Our team of 7,500+ colleagues helps make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of 270+ high- quality medicines.
Looking for candidates with relevant experience in OSD regulated plants for the following QC roles: QC - GLP, Technical Writer, and Audit Trail.
Quality Control - GLP Executive / Sr. Executive
Qualification : MSc/B Pharm/ M Pharm
Experience : 07-10 Years
Required skills : • Perform IQ/OQ/PQ, CSV, calibration, and qualification of laboratory instruments and systems.
• Manage GLP incidents, deviations, investigations, CAPA, and Data Integrity requirements.
• Handle LIMS operations, instrument maintenance, and lifecycle management.
• Prepare and review SOPs, calibration records, technical agreements, and GLP documentation.
• Coordinate vendors, audits, analyst training, and regulatory compliance (USFDA/EU).
Quality Control - Technical Writer Sr. Officer / Executive
Qualification : MSc / B Pharm / M Pharm
Experience : 05 - 07 Years
Required skills : • 5+ years' experience in pharma technical writing or QC documentation.
• Excellent analytical, writing & communication skills.
• Strong knowledge of pharmacopeial & regulatory standards.
• Prepare, review & update QC documents (SOPs, reports, protocols).
• Collaborate with cross-functional teams to ensure compliance & accuracy.
Quality Control - Audit Trail Sr. Executive / Asst. Manager
Qualification : MSc / B.Pharm / M.Pharm
Experience : 08 -12 Years
Required skills : • Review QC computerized system audit trails (Empower, LIMS, HPLC, GC, UV, Dissolution, Malvern, etc.) for Data Integrity compliance.
• Identify, assess, and document audit trail events as per approved SOPs and cGMP requirements.
• Investigate discrepancies/unusual events, perform root cause analysis, and prepare investigation reports.
• Ensure timely closure of audit trail observations and maintain ALCOA+ and 21 CFR Part 11 compliant records.
Job Location : Rajoda, Ahmedabad
Only relevant candidates may share their updated resumes with : aartig@amneal.com | princy.kumari@amneal.com
Disclaimer : Amneal ensures equal job opportunities and does not charge applicants for employment or authorize any agency to collect fees for recruitment.
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