Sr. Executive

Lupin Ltd; Chhatrapati Sambhajinagar District; On-site; INR 1,200,000 - 2,200,000; Full time

Job summary

Lupin Ltd is seeking an experienced QA/QAMS professional to review quality system documents and SOPs, oversee CAPA and change control processes, and ensure compliance across batch records. The role includes risk management review, validation document oversight, and handling market complaints investigations.

Ideal candidates have 7–10 years in pharma QA with Graduation in Pharmacy and strong experience in QAMS activities, OOS/OOT and regulatory aligned documentation.

Qualifications

• Review of various quality system documents.
• Preparation and review of Standard Operating Procedures.
• Handling of QAMS activities like change control, OOS, OOT, Deviations, Lab Incidences and CAPA etc.
• Preparation and review of quality risk management.
• Review of batch manufacturing record and batch packing records.
• Review, assessment and closure of other QAMS documents whenever required.
• Review of validation and qualification documents.
• Handling of market complaint and participate in investigation.

Responsibilities

• Review of quality system documents for adequacy and compliance.
• Prepare and review Standard Operating Procedures across QA processes.
• Oversee QAMS activities including change control, OOS, OOT, deviations and CAPA.
• Contribute to quality risk assessments and mitigations.
• Review batch manufacturing and batch packing records for accuracy.
• Close out QAMS documents after thorough evaluation.
• Validate and qualify documentation as required.
• Investigate and address market complaints.

Skills

Quality systems

SOP preparation

QAMS activities

CAPA handling

Investigation

Education

Graduation in Pharmacy

Job description

Job Description

• Review of various quality system documents.
• Preparation and review of Standard Operating Procedures.
• Handling of QAMS activities like change control, OOS, OOT, Deviations, Lab Incidences and CAPA etc.
• Preparation and review of quality risk management.
• Review of batch manufacturing record and batch packing records.
• Review, assessment and closure of other QAMS documents whenever required.
• Review of validation and qualification documents.
• Handling of market complaint and participate in investigation.

Work Experience

7- 10 years

Education

Graduation in Pharmacy

Job Description

• Review of various quality system documents.
• Preparation and review of Standard Operating Procedures.
• Handling of QAMS activities like change control, OOS, OOT, Deviations, Lab Incidences and CAPA etc.
• Preparation and review of quality risk management.
• Review of batch manufacturing record and batch packing records.
• Review, assessment and closure of other QAMS documents whenever required.
• Review of validation and qualification documents.
Handling of market complaint and participate in investigation.

Work Experience

7- 10 years

Education

Graduation in Pharmacy