Website:
bioksha.in
Job details:
Division
Department
Sub Department 1
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
Key Accountabilities (1/6)
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
Key Accountabilities (2/6)
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
Key Accountabilities (3/6)
Document all activities performed as per valid procedure online by using standard/approved formats or templates to ensure that all entries done are correct, accurate and authentic
- Maintain system integrity by updating documentations and deviations on CipDox while performing operations
- Maintain all the online documentation and timely entries and supporting documents
- Prepare new documents and update existing documents as per GMP requirement
Key Accountabilities (4/6)
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
Key Accountabilities (5/6)
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
Key Accountabilities (6/6)
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
Key Interactions (1/2)
- 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)
Key Interactions (2/2)
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
Dimensions (2/2)
Key Decisions (1/2)
- Process simplification and modification to other locations CDC / Section Head – CDC
- Resolution of user queries to Section Head – CDC
Key Decisions (2/2)
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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