Cipla Hiring for Team Member – QC

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

Prepare documents like SOPs, specifications and non-routine documentation and ensure timely availability across the site to provide support during the analysis 

Prepare / revise corporate documents like SOPs, general analytical methods etc. by coordinating with site QC/QA

Review the applicable pharmacopoeia and guidelines and make appropriate updates

Review instrument calibration data w.r.t  operating documents

Review  the latest pharmacopeial updates, supplements and amendments by evaluating the updates required in the available document to ensure the compliance with the current pharmacopoeia through consent with regulatory body

Review the new/revised monograph as per current pharmacopoeia

Review the latest pharmacopeial updates and monitor its timely implementation to avoid any non-conformances

Intimate the concerned stakeholders to initiate and complete activities before effective date of pharmacopoeia

Escalate non-conformances timely to avoid any delays in operation

Review the assigned documents by referring the concern backup and pre-defined quality procedure to ensure its compliance against the quality requirements

Follow the approved procedures and current Cipla policies for review approach by referring valid backup documents, SOPs etc. so that every document is complying w.r.t. the quality aspect of the product

Identify and discuss queries / problems faced during the document review by taking initiatives so that further delay in document completion is avoided

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

Issue applicable bound books to units by maintaining the log of the same so the current format is available to record the relevant data entries

Maintain correct and updated record of all the issuance of documents and bound books

Execute harmonization and simplification process of documents to reduce complexities in processes 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

Major Challenges

Delay in verification of methods for pharmacopeial updates due to non-availability of data. Overcome by coordinating with QC and

Inadequate time allotted for updating the documents due to late intimations and change in priorities. Overcome by understanding the requirements and proper planning and coordination with CFTs

Delay in meeting final timelines of the activities due to delay in getting review comments for cross functional departments. Overcome by regular follow-ups and escalations

Internal

CDC / QC / QA / RA to get approval on documents (Daily)

ADL / R&D to get data for document updates for deficiency response  (Need Basis)

IPD to get data for document updates for new projects (Need Basis)

Dimensions (1/2)

Number of units supported for documents update : 4

Average number of documentation (preparation/review) per months : 10

Achieve finalization of NLT 80% documents within defined timeline

Ensure 100% implementation of pharmacopoeial updation after getting supporting data

Recommendations

Process simplification and modification to other locations CDC / Section Head – CDC

Resolution of user queries to Section Head – CDC

Education Qualification

M.Sc. / B. Pharma.

Relevant Work Experience

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

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