Officer

Lupin; Dhar; On-site; INR 600,000 - 1,100,000; Full time

Job summary

Lupin in Dhar, India, seeks an experienced QA professional to prepare and review SOPs for the QA system and support SOP approvals across departments. The role focuses on ensuring GMP-compliant documentation and batch readiness.

Key responsibilities include reviewing master BMR/BPR for commercial and exhibit batches, assisting with scale-up, performing in-process QA, and participating in deviation investigations to ensure timely batch releases.

Qualifications

• Preparation & Review of SOPs of QA system and review/approval of SOPs 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 and destruction of SOPs, 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.

Responsibilities

• Preparation and review of SOPs for QA and other departments.
• Review and approval of BMR/BPR and batch scale-up.
• Investigations of failures and batch release support.
• In-process QA during production and packing.
• Shop floor monitoring for compliance.

Skills

QA systems

SOP review

QA documentation

Batch release coordination

Investigation of deviations

Education

Graduation in Pharmacy

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.

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