21 Aug
|
Selway LifeSciences Private
|
Indore
21 Aug
Selway LifeSciences Private
Indore
A Quality Assurance (QA) Manager in a pharmaceutical company leads compliance, manages quality systems, and oversees batch releases. Core duties include maintaining cGMP standards, handling deviations and CAPAs, and hosting regulatory audits.
Key Responsibilities
· Batch Release: Review and approve batch manufacturing records (BMR) and authorize final product disposition.
· Compliance & Audits: Maintain the Quality Management System (QMS), conduct internal audits, and manage inspections from regulatory bodies like the FDA.
· CAPA & Deviations: Lead root-cause investigations for process deviations, out-of-specification (OOS) results, and implement corrective and preventive actions.
· Documentation: Author, review, and update Standard Operating Procedures (SOPs) and validation protocols.
· Team Leadership: Train, mentor,
and manage QA staff to foster a strong culture of quality compliance.
Qualifications & Skills
· Education: Bachelor's or Master's degree in Pharmacy (B.Pharm / M.Pharm), Chemistry, Microbiology, or related Life Sciences.
· Experience: 5 years of total experience in pharmaceutical quality assurance or manufacturing environment.
· Knowledge: Deep expertise in cGMP, GLP, ICH guidelines, and regulatory compliance standards.
· Skills: Robust leadership, root-cause analysis, attention to detail, and cross-functional communication.
Pay: ₹50,000.00 - ₹60,000.00 per month
Work Location: In person
📌 Quality Assurance (QA) Manager (Indore)
🏢 Selway LifeSciences Private
📍 Indore