About CLYZO
CLYZO is a rapidly growing Pharma B2B platform backed by 14+ years of expertise in pharmaceutical raw materials, APIs, bulk drugs, excipients, and specialty chemicals. We partner with leading pharmaceutical manufacturers across India, delivering reliable sourcing solutions, manufacturing excellence, regulatory compliance, and efficient supply chain support.
Lead – Quality Assurance (Bulk Drugs & APIs)
Location: Mahape, Navi Mumbai
We are seeking an experienced Lead – Quality Assurance (Bulk Drugs & APIs) to lead Quality Systems, Regulatory Compliance, Audit Management, and Continuous Improvement initiatives across our manufacturing operations. The role requires strong expertise in pharmaceutical quality management, regulatory compliance, and plant quality leadership.
Key Responsibilities
- Lead and strengthen Quality Management Systems (QMS) and ensure compliance with GMP, WHO-GMP, ICH Guidelines, and Data Integrity requirements.
- Manage CAPA, Change Controls, Deviations, OOS/OOT investigations, Risk Assessments, and Audit Readiness.
- Oversee raw material inspection, in-process controls, finished product release, validation activities, and quality documentation.
- Drive SOP implementation, process standardization, quality improvements, and operational excellence initiatives.
- Lead internal, customer, supplier, and regulatory audits and ensure timely closure of audit observations.
- Monitor quality KPIs, customer complaints, rejections, and process deviations while implementing corrective and preventive actions.
- Collaborate with Production, QC, Engineering, Supply Chain, Warehouse, and R&D teams to ensure consistent quality performance.
- Lead, mentor, and develop the QA team while promoting a strong culture of quality and compliance.
Qualifications & Experience
- B.Pharm, M.Pharm, M.Sc. Chemistry, Biotechnology, Pharmaceutical Sciences, or related discipline.
- 3–7 years of Quality Assurance experience in APIs, Bulk Drugs, Excipients, Specialty Chemicals, or Pharmaceutical Raw Materials.
- Experience handling regulatory inspections, customer audits, supplier audits, and plant quality operations.
- Strong knowledge of GMP, WHO-GMP, QMS, Data Integrity, Validation, CAPA, and Regulatory Compliance.
- Hands-on experience with HPLC, GC, GC-MS, and related analytical techniques.
- Strong leadership, problem-solving, stakeholder management, and cross-functional coordination skills.
- Hands-on experience handling US FDA, WHO-GMP, and customer audits, Quality Management Systems (QMS), Data Integrity, Validation, CAPA, Deviations, Change Control, and regulatory compliance.
Preference will be given to candidates with proven experience in API, Bulk Drug, Excipient, or Specialty Chemical manufacturing facilities and strong exposure to regulatory audits, quality systems, and plant QA leadership.
Pay: ₹300,000.00 - ₹700,000.00 per year
Benefits:
Work Location: In person
