Manager

Lupin Ltd; Aurangabad; Presencial; INR 1.500.000 - 2.500.000; Jornada completa

Descripción de la vacante

Lupin Ltd in India seeks an experienced QA professional to lead the review and approval of master documents, quality system records, and batch-related documentation. You will drive investigations, CAPA, recalls, and deviations to support compliant product releases.

You will participate in validation activities, risk assessments, and annual product quality reviews, ensuring SAP-based release controls and robust site quality management. A pharmacy degree with 10–12 years’ experience is required.

Formación

• 10-12 years of QA/QMS experience in pharma manufacturing.
• Graduation in Pharmacy.
• Experience with GMP/QA documentation and SAP.

Responsabilidades

• Review and approve master documents (SOPs, specs, STPs, OPML, batch records, stability protocols).
• Review and approve QA system documents (change control, CAPA, deviations, OOS/OOT, complaints).
• Investigate deviations, complaints, and incidents; coordinate recalls and returns.
• Review validation protocols and annual product quality reviews.
• Perform quality risk assessments and ensure SAP release controls.
• Prepare and review hold time studies and ensure site QC documentation.

Conocimientos

Collaboration

Customer Centricity

Developing Talent

Innovation

Creativity

Process Excellence

Result Orientation

Stakeholder Management

Strategic Agility

Educación

Graduation in Pharmacy

Herramientas

SAP

Descripción del empleo

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

Competencies

• Collaboration
• Customer Centricity
• Developing Talent
• Innovation & Creativity
• Process Excellence
• Result Orientation
• Stakeholder Management
• Strategic Agility