Manager - Quality Assurance
- Location
- Patas, Maharashtra, India
- Salary
- Not specified
- Company
- Akash pawar
Job description
Role & Company / Project Overview: Steribio Lifesciences Pvt. Ltd. is looking for an experienced and detail-oriented Manager - Quality Assurance to lead the QA function at its LVP manufacturing facility located at Patas, Maharashtra. The role is focused on ensuring regulatory compliance and strengthening pharmaceutical quality systems to maintain the highest standards of product quality and patient safety. 01 open position available. Key Responsibilities & Daily Duties: • Lead the Quality Assurance function for LVP / sterile manufacturing operations. • Ensure compliance with GMP, Schedule M, WHO-GMP, and applicable regulatory requirements. • Oversee batch documentation review, product disposition, and QA release as per approved procedures. • Manage quality systems including Deviations, OOS/OOT, CAPA, Change Control, and Quality Risk Management. • Provide QA oversight for validation, qualification, sterile manufacturing processes, and critical pharmaceutical systems. • Ensure effective implementation of SOPs, document control, training, and Data Integrity / ALCOA+ principles. • Lead internal audits, self-inspections, customer audits, and regulatory inspection readiness. • Oversee product complaints, recalls, PQR/APR, and related investigations, as applicable. • Drive continuous improvement of quality systems and promote a strong GMP and compliance culture. • Lead, mentor, and develop the QA team, ensuring accountability and operational effectiveness. • Collaborate with Production, QC, Engineering, Warehouse, and other cross-functional teams to ensure consistent quality compliance. Required Qualifications, Skills & Experience: • Educational Qualification: B.Pharm / M.Pharm / M.Sc. or equivalent qualification in Pharmaceutical Sciences, Chemistry, or relevant Life Sciences. • Postgraduate qualification (M.Pharm) in Quality Assurance or Pharmaceutical Sciences is preferred. • Experience: 8 to 12 years of relevant experience in Pharmaceutical Quality Assurance. • Strong hands-on experience in LVP / IV Fluids / Sterile / Parenteral manufacturing is highly preferred. • Strong knowledge of GMP, Schedule M, WHO-GMP, and Pharmaceutical Quality Management Systems. • Practical experience in batch review/release, deviations, investigations, CAPA, Change Control, and validation. • Direct exposure to regulatory, customer, and internal audits/inspections. • Clear understanding of sterile manufacturing practices, cleanroom controls, and contamination control. • Strong leadership, communication, analytical, and problem-solving skills. • Ability to independently drive quality and compliance initiatives and collaborate across departments. • High level of integrity, attention to detail, and commitment to product quality and patient safety. Working Hours, Shifts & Location Details: • Location: Patas, Maharashtra, India (Factory Location: Gat No 148, A/p, near Patas Toll Plaza, Naka, Patas). • Work Type: In Person. Compensation & Benefits: • Compensation details are not disclosed in the announcement. Application Instructions: • Eligible candidates should review the requirements carefully and send their updated resume directly to the HR department via email.