Team Member – Documentation Job Vacancy in Cipla Vikhroli, Mumbai, Maharashtra – Latest Jobs in Vikhroli, Mumbai, Maharashtra

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Full Details :
Company Name : Cipla
Location : Vikhroli, Mumbai, Maharashtra
Position : Team Member – Documentation

Job Description : Division

Quality

Department

Corporate Quality Assurance

Sub Department 1

Commercial Compliance and Quality System

Job Purpose

Prepare, update and review the Lab SOPs, IOP, EOP, policy and GAM’s documents for analysis of materials in order to ensure alignment to predefined quality parameters and compliance to respective regulatory standards / pharmacopeia and cGMP/ GLP requirements.

Accountabilities
Preparation, Review and Approval of corporate documents.
Responsible to ensure the Lab SOPs are in compliance with current guidelines, statutory and company standards during preparation and review of the SOPs.
Responsible for circulation of the draft SOP’s for comments and co-ordination with all concerned for receipt of comments within reasonable time.
Review of comments received and taking appropriate decision in consultation with relevant stakeholders before finalization of the CQA document.
Responsible for preparation and filling of required documents like change request, review sheet, etc. as part of requirements of CQA document revision.
Resolving queries related to CQA SOPs / documents.
Responsible to operate software such as CipDox, Trackwise, LIMS and LMS etc. based on the roles and rights provided in the application.
Responsible for taking follow-up for implementation, close-out of Change Request and maintenance of appropriate records of the same.
Execute harmonization and simplification process of documents to reduce complexities in processes and ensure standardized procedures are followed.
Education Qualification

B. Sc. / M. Sc. (Chemistry)/ M. Pharm

Relevant Work Experience

6-8 years of experience in QC department of a pharmaceutical organization

Competencies/Skills
Communication Skills (clarity of thought, comprehension)
Likely potential for growth
Job / Product / Technical Knowledge / Pharma domain knowledge
Presentation & Interpersonal skills (If applicable)
Safety awareness (If applicable)
Relevance of Previous Experience
Comprehension, Analytical & Problem solving abilities
Productivity & Result Orientation (If applicable)
Attitude
Qualification fitment
Sales drive (If applicable)
Personality traits (Individualistic / Team player, Out spoken, Maturity level etc.)
16. Technology Utilization
Job Location

Vikhroli, Mumbai.

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