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Lupin

Officer -QA

Lupin Chungthang, Sikkim, India

Pharmaceutical Manufacturing · 10,001+ employees

Aug 24
qa Mid (2-5 yrs) Full-time India
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About the role

The Officer will ensure compliance with SOPs and cGMP requirements on the shop floor while monitoring manufacturing processes to prevent contamination. They are responsible for reviewing batch records, performing in-process checks, and executing validation protocols.

What they look for

Quality Assurance Batch Records SOP Compliance cGMP Line Clearance In-process Checks Sampling Process Validation Cleaning Validation Cleaning Verification SAP Product Investigation System Failure Analysis Technical Training

Requirements

Candidates must hold a graduation degree in Pharmacy and possess 2-4 years of relevant work experience. Strong knowledge of cGMP standards and manufacturing documentation is required.

Full description

Job Description

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Compliance to the instructions given in Batch records of various products.

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Ensuring the compliance of the SOPs and cGMP requirements at shop floor.

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Ensuring no mix-ups, contamination and cross contamination of the products during all stages of manufacturing means of “Line Clearance” and continuous monitoring the process.

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Performing “In-process Checks” at different stages of manufacturing for various products and ensuring the compliance.

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“Sampling” at different stage of manufacturing or as per the requirement.

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Stage wise review of batch records and compliances if any, to facilitate timely release.

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Preparation, execution and compilation of process validation (Process performance qualification) and cleaning validation & cleaning verification.

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Review of master batch manufacturing record and batch packing record in SAP.

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Active participation in investigation related to product / system failure.

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Ensuring the awareness of cGMP and its requirement to the technicians/concerns through continuous interaction/SOP training.

Work Experience

2-4 years

Education

Graduation in Pharmacy

Competencies

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