Manager

Lupin; Chhatrapati Sambhajinagar District; Sur place; INR 1 200 000 - 1 800 000; Plein temps

Résumé du poste

Lupin is seeking an experienced quality professional in Maharashtra to review and approve master documents, SOPs, batch records and stability protocols. The role involves ensuring compliance through QAMS, CAPA tracking and incident investigations.

With 10-12 years in pharma quality, you will lead inspections, participate in recalls, and coordinate with cross-functional teams to maintain GMP standards and product quality across markets.

Qualifications

• 10-12 years of work experience in quality assurance or related domain.
• Graduation in Pharmacy from a recognized institution.
• Customer centricity, developing talent, process excellence and result orientation are valued.
• Strong stakeholder management and strategic agility are preferred.

Responsabilités

• Review and approval of master documents such as SOPs, specifications, STPs, OPML, batch manufacturing and packing records and stability protocols.
• Review and approval of quality system documents like change control, market complaints, deviations, OOS, OOT and CAPA in QAMS.
• Participate in investigations of deviations, market complaints, OOS/OOT and incidents.
• Handle recall and return goods, Field Alert Reports and CAPA; participate in self-inspection.
• Review validation protocols and annual product quality reviews of drug products.

Connaissances

Quality Assurance

Documentation review

Stakeholder management

Process excellence

Formation

Bachelor of Pharmacy

Outils

SAP

Description du poste

• 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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