Manager

Lupin; Aurangabad; On-site; INR 1,200,000 - 2,000,000; Full time

Job summary

Lupin in Aurangabad (India) seeks a seasoned Quality Assurance professional with 10–12 years of pharma QA experience to lead review and approval of master documents, change controls, CAPA investigations, and recalls. The role emphasizes SAP-based release decisions and rigorous QA governance across the site.

The ideal candidate holds a Pharmacy degree, demonstrates stakeholder management and process excellence, and drives strategic QA initiatives aligned with Lupin’s Quality Management System.

Qualifications

• 10–12 years of quality assurance/QA experience in pharma
• Graduation in Pharmacy is required
• Experience with QA systems (SOPs, CAPA, change control) preferred

Responsibilities

• Review and approve master QA documents (SOPs, specifications, batch records, stability protocols)
• Review and approve quality system documents (change control, CAPA, deviations, OOS/OOT)
• Participate in investigations of deviations and market complaints
• Handle recalls/returns, Field Alert Reports, and self-inspections
• Review validation protocols and annual product quality reviews of drug products
• Perform quality risk assessments
• Prepare/review hold time study protocols and reports
• Maintain site quality management details
• Release or reject finished products in SAP for market distribution
• Approve documents in SAP and ensure department/equipment compliance

Skills

Customer centricity

Talent development

Process excellence

Result orientation

Stakeholder management

Strategic agility

Education

Bachelor's degree in Pharmacy

Job description

• Review and Approval of master documents like SOPs, specification, STPs, OPML, batch manufacturing, batch packing records and stability protocol.
• Review and Approval of quality system documents like change control, market complaints, deviation, OOS, OOT, CAPA etc. in QAMS.
• Review and participation in investigation of deviations, market complaints, OOS/OOT, incidents etc.
• Handling of recall and return goods, Field Alert Report, CAPA and participate in self inspection.
• Review of validation protocols, annual product quality review of drug product
• Perform the Quality risk assessment
• Preparation and review of hold time study protocols and reports.
• Review and maintain site quality management details
• Release or rejection of finished products in SAP for market distribution.
• Approval of various documents in SAP system
• To check the maintenance of the department, premises and equipment/instrument

Work Experience

10-12 years

Education

Graduation in Pharmacy

Customer Centricity

Developing Talent

Process Excellence

Result Orientation

Stakeholder Management

Strategic Agility

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