Job Description

Division

Quality

Department

Quality

Employment Type

Permanent

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

I. 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

II. 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 activitiarmacopoeia
Escalate non-conformances timely to avoid any delays in operation

III. 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

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

V. 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

Education Qualification

M.Sc. / B. Pharma

Relevant Work Experience

1-3 years of experience in QC department of a pharmaceutical organization

Competencies/Skills

Collaborate to Succeed

Innovate to Excel

Perform with Accountability

Lead with Empathy

Act with Agility

Strong Domain Knowledge

People Management

Job Location

Goa

Shift Hours

Cipla