Manager

Lupin Limited; Chhatrapati Sambhajinagar District; Vor Ort; INR 2.400.000 - 3.600.000; Vollzeit

Zusammenfassung

Lupin Limited in Maharashtra, India is seeking an experienced Senior QA professional to drive the review and approval of master quality documents and system records. The role involves oversight of CAPA, deviations, OOS/OOT investigations, and field alerts, while ensuring compliance with SAP-based release processes.

The ideal candidate will have a pharmacy degree with 10–12 years of QA experience, strong collaboration skills, and a track record in process excellence and stakeholder management

Qualifikationen

• Review and approve master documents including SOPs, specifications, STPs, OPML, batch manufacturing and batch packing records, and stability protocols.
• Review and approve quality system documents such as change control, market complaints, deviations, OOS, OOT, CAPA in QAMS.
• Investigate deviations, market complaints, OOS/OOT and incidents; participate in self-inspection.
• Handle recalls and return goods, Field Alert Reports, CAPA activities and related investigations.
• Review validation protocols and annual product quality review of drug products.
• Perform quality risk assessments.
• Prepare and review hold time study protocols and reports.
• Review and maintain site quality management details and ensure quality across processes.

Aufgaben

• Review and approval of master quality documents and batch records.
• Oversee QAMS quality system documents and CAPAs.
• Participate in investigations of deviations and complaints.
• Support recalls, Field Alert Reports and recalls processes.
• Validate protocols and conduct quality reviews on product quality.

Kenntnisse

Collaboration

Customer Centricity

Developing Talent

Innovation & Creativity

Process Excellence

Result Orientation

Stakeholder Management

Strategic Agility

Ausbildung

Graduation in Pharmacy

Tools

SAP

Jobbeschreibung

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