Cipla is hiring for the role of Team Member – QC at Rangpo, Sikkim, India. This opportunity is suitable for candidates with quality control experience in a pharmaceutical organization and knowledge of regulatory standards, compliance norms, pharmacopeia and cGMP requirements.

Job Details

Job Description

The Team Member – QC will prepare, update and review specifications, SOPs, policies and operating documents for the analysis of materials. The role is focused on ensuring alignment with predefined quality parameters and compliance with respective standards, pharmacopeia and cGMP requirements.

Key Responsibilities

• Prepare documents such as SOPs, specifications and non-routine documentation, and ensure timely availability across the site to support analysis activities.
• Prepare and revise corporate documents such as SOPs and general analytical methods by coordinating with site QC/QA teams.
• Review applicable pharmacopoeia and guidelines and make appropriate updates.
• Review instrument calibration data with respect to operating documents.
• Review the latest pharmacopeial updates, supplements and amendments by evaluating updates required in available documents to ensure compliance with current pharmacopoeia through consent with the regulatory body.
• Review new or revised monographs as per current pharmacopoeia.
• Monitor timely implementation of pharmacopeial updates to avoid non-conformances.
• Intimate concerned stakeholders to initiate and complete activities before the effective date of pharmacopoeia.
• Escalate non-conformances in a timely manner to avoid delays in operation.
• Review assigned documents by referring to the concerned backup and predefined quality procedure to ensure compliance with quality requirements.
• Follow approved procedures and current Cipla policies for the review approach by referring to valid backup documents, SOPs and related documents.
• Identify and discuss queries or problems faced during document review by taking initiatives to avoid delays in document completion.
• Issue documents to applicable units and maintain records in the issuance record so that the current version of the common document is available at the unit.
• Issue applicable bound books to units by maintaining the log so the current format is available to record relevant data entries.
• Maintain correct and updated records of all issuance of documents and bound books.
• Execute harmonization and simplification of documents to reduce process complexities and ensure standardized procedures are followed.
• Evaluate and prepare documents for standardization across all units at a site.
• Coordinate with CFTs and check requirements as per existing procedures to simplify the process.
• Provide suggestions and ideas by exploring new possibilities to achieve work simplification.

Qualification

• M.Sc. / B. Pharma.

Experience

Candidates should have 1-3 years of experience in the QC department of a pharmaceutical organization with knowledge of the latest regulatory standards and compliance norms.

Key Interactions

• CDC / QC / QA / RA to get approval on documents on a daily basis.
• ADL / R&D to get data for document updates for deficiency response on a need basis.
• IPD to get data for document updates for new projects on a need basis.

Role Dimensions

• Number of units supported for documents update: 4.
• Average number of documentation preparation/review per month: 10.
• Achieve finalization of NLT 80% documents within defined timeline.
• Ensure 100% implementation of pharmacopoeial updation after getting supporting data.

How to Apply

Interested candidates should review the official job details and apply through the official Cipla careers application page.

Candidates are advised to verify all details on the official application page before applying.

Author: PharmaBharat Editorial Team