Officer

Lupin; Dhar; Presencial; INR 600 000 - 900 000; Tempo integral

Resumo da oferta

Lupin Ltd. in Dhar, Madhya Pradesh, seeks a Quality Assurance professional to prepare and review SOPs, ensure QA compliance across departments, and participate in batch release activities for commercial and exhibit batches.

The role covers in-process QA during production, review of BMR/BPR, qualification/validation documents, and investigation of failures to ensure product quality and regulatory adherence.

Qualificações

• Experience in QA systems and SOP handling.
• Review and approval of master documents (BMR/BPR).
• Experience with batch release and investigation of deviations.

Responsabilidades

• Prepare and review SOPs for QA and other departments.
• Review master BMR/BPR, scale-up, and batch-related documents.
• Oversee batch release for commercial and exhibit batches.
• Manage document issuance, retrieval, and destruction of QA formats.
• Review Deviation/IPQOS and participate in investigations.
• Provide in-process QA during production and packing activities.
• Sample at various manufacturing stages as required.
• Review qualification/validation documents and stability data.
• Investigate failures and support batch releases.
• Monitor shop floor for compliance with procedures.

Conhecimentos

Quality Assurance

SOP Review

BMR/BPR Review

Deviation Investigation

Batch Release

Formação académica

Graduation in Pharmacy

Descrição da oferta de emprego

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