Quality Assurance Officer

lupin ltd; Pithampur; On-site; INR 600,000 - 900,000; Full time

Job summary

Lupin Ltd in India is seeking an Officer to support QA activities. The role involves preparing and reviewing SOPs for the QA system, approving SOPs across departments, and auditing master BMR/BPR for commercial and exhibit batches.

Responsibilities include in-process QA during production/packing, batch review for releases, and participation in investigations of failures with strict shop-floor compliance. Graduation in Pharmacy and 5–8 years’ experience are expected.

Qualifications

• Graduation in Pharmacy.
• 5–8 years of work experience in QA/pharma environments.
• Knowledge of GMP/GDP and QA documentation.

Responsibilities

• Prepare & review SOPs for QA system and approve SOPs from other departments.
• Review master BMR/BPR for commercial and exhibit batches.
• Review BMR/BPR, scale-up and placebo batches.
• Review executed BMR/BPR for batch release.
• Manage issuance, retrieval and destruction of SOPs, STP, specifications and annexures.
• Login and review quality system documents (Deviation, IPOOS).
• In-process QA during production/packing.
• Sampling at manufacturing/packing stages (In-process, BU, CU, finished, control, QP, hold time, stability).
• Review qualification/validation documents and stability data.
• Participate in investigation of failures and batch releases.
• Shop floor monitoring for compliance with procedures.
• Prepare, review and track hold time protocols/reports.

Skills

SOP review

QA systems

BMR/BPR review

Batch release

Deviation handling

In-process QA

Sampling

Validation docs

Investigations

Shop floor monitoring

Education

Graduation in Pharmacy

Job description

• Officer Job Description Preparation & Review of SOP’s of QA system and review / approval of SOP’s of other departments.


• Review of master BMR/BPR of commercial and exhibit batches.


• Review of BMR / BPR, scale-up and placebo batches.


• Review of executed BMR/BPR of commercial and exhibit batches for batch release.


• Issuance, Retrieval & Destruction of SOP’s, STP, specification, BMR/BPR, annexures & other formats.


• Login and review of quality system documents such as Deviation and IPOOS.


• In-process Quality Assurance during Production / Packing activities.


• Sampling at different stages of manufacturing / packing as per the requirement (In-process, BU, CU, finished, control, QP, Hold Time & stability etc.)


• Review of qualification / validation documents, stability data and Executed documents.


• Participation in investigation of failures and release of batches.


• Shop floor monitoring and ensuring the compliance as per designed procedures.


• Preparation, review and tracking of hold time protocols / reports


• Work Experience 5 to 8 year


• Education Graduation in Pharmacy


• Competencies


• Experience Level Mid Level