Cipla Lmited Vacancy QA-QC

Cipla Limited – QA/QC – B.Pharma / M.Sc.

Cipla Limited is hiring for the following positions of “Junior Team Member – QA/QC”.

About Cipla Limited

Cipla Limited is an Indian multinational pharmaceutical company, headquartered in Mumbai, India. Cipla primarily develops medicines to treat respiratory, cardiovascular disease, arthritis, diabetes, weight control, and depression; other medical conditions. Cipla, as an organization has been built brick-by-brick on the foundation of care. Caring For Life has always been and continues to remain, our guiding purpose. Driven by the same purpose, we have extended our presence to 80+ countries providing over 1,500 products across various therapeutic categories in 50+ dosage forms. To make healthcare more affordable globally, we are deepening our presence in the key markets of India, South Africa, the U.S. among other economies of the emerging world.

Job Description

>>Junior Team Member – QA

Qualification: B. Pharma / M.Sc.

Work Experience: 2 years of experience in the quality assurance department

Job Location: Patalganga, Maharashtra, India

Job Purpose: Review the compliance level of the site for deficiency response, prepare master validation protocol, and report as per company quality policy and applicable regulatory guidelines.

Accountabilities:

  • Collate, review, and provide required work plans on received deficiencies to HO in order to respond to regulatory authorities in a timely manner.
  • Review Master Validation protocol and report for timely execution of validation batches and timely submission of documents in order to respond to deficiencies.
  • Review annual product quality review reports at units for completeness and data correctness to ensure compliance to cGMP requirements and audit readiness.
  • Review, upkeep and issue regulated market technical agreements at site for execution of batches as per customer requirement.
  • Receive and distribute approval certificate, dossiers (TDP & RAP) and development report at unit for execution of new products smoothly.
  • Coordinate with auditors and site teams for regulatory and customer inspection/ audit at site to meet regulatory expectations and acquire GMP approvals.
  • Prepare final draft of compliance to audit observation and check whether it is in line with cGMP requirement to avoid regulatory action and continual improvements.
  • Collect, compile and review raw data and finalise the same for timely submission of MHRA, UK interim update document to corporate as per agency requirement by tracking interim updates at a site level, for risk based inspection planning.
  • Drive continuous improvement initiatives in CQA to facilitate adherence to cGMP.
  • Execute on time and errorless submissions by reviewing product license, all certificates for product registration and tender , staff approvals and other applications to adhere to legal requirements.
  • Support in CDSCO and state FDA inspection to be GMP compliant and getting product licence, FDA stall approvals by ensuring cross functional interaction.

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>>Junior Team Member – QC

Qualification: B. Pharma / M.Sc.

Work Experience: 2 years of experience in the QC department of a pharmaceutical organization

Job Location: Goa, India

Job Purpose: Prepare, update and review the specifications, SOPs, policy, and operating documents for analysis of materials in order to ensure alignment to predefined quality parameters and compliance to respective standards/pharmacopeia and cGMP requirements.

Accountabilities:

  • Prepare documents like SOPs, specifications, and non-routine documentation and ensure timely availability across the site to provide support during the analysis.
  • Review the latest pharmacopeial updates, supplements, and amendments by evaluating the updates required in the available documentation to ensure compliance with the current pharmacopeia through consent with the regulatory body.
  • Review the assigned documents by referring to the concern backup and pre-defined quality procedure to ensure its compliance against the quality requirements.
  • Issue documents to applicable units, by maintaining the record of the same in the issuance record (bound book) so the current version of the common document is available at the unit.
  • Execute harmonization and simplification process of documents to reduce complexities in processes and ensure standardized procedures are followed.

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