Cipla QA Job For BPharma Candidates – Apply Online
Cipla is a renowned pharmaceutical company known for its commitment to quality and innovation in healthcare. With a global presence and a wide range of products, Cipla has been dedicated to improving the lives of patients around the world. As a Junior Team Member in the Quality Assurance department, you will have the opportunity to contribute to Cipla’s mission and be a part of a talented team.
Position: Junior Team Member – QA
Requisition ID: 81689
Posted: 01/17/2024
Location: India – Sikkim – Rangpo
Division: Quality
Department: Quality
Employment Type: Permanent
Job Purpose
Review the compliance level of the site for deficiency response, prepare master validation protocol and report as per the company’s quality policy and applicable regulatory guidelines.
Accountabilities
I. Collate, review and provide required work plans on received deficiencies to HO in order to respond to regulatory authorities in a timely manner
II. Review Master Validation protocol and report for timely execution of validation batches and timely submission of documents in order to respond to deficiencies
III. Review annual product quality review report at units for completeness and data correctness to ensure compliance with cGMP requirements and audit readiness
IV. Review, upkeep
and issue regulated market technical agreements at the site for the execution of batches as per customer requirementsV. Receive and distribute approval certificate, dossiers (TDP & RAP), and development reports at the unit for the smooth execution of new products
VI. Coordinate with auditors and site teams for regulatory and customer inspection/audit at the site to meet regulatory expectations and acquire GMP approvals
VII. Prepare the final draft of compliance to audit observations and check whether it is in line with cGMP requirements to avoid regulatory action and continual improvements
VIII. Collect, compile and review raw data and finalize the same for timely submission of MHRA, UK interim update document to corporate as per agency requirement by tracking interim updates at a site level, for risk-based inspection planning
IX. Drive continuous improvement initiatives in CQA to facilitate adherence to cGMP
X. Execute on time and errorless submissions by reviewing product license, all certificates for product registration and tender, staff approvals, and other applications to adhere to legal requirements
XI. Support in CDSCO and state FDA inspection to be GMP compliant and getting product license, FDA stall approvals by ensuring cross-functional interaction
Education Qualification
B. Pharma/ M.Sc
Relevant Work Experience
2 years of experience in the quality assurance department
Competencies/Skills
- Collaborate to Succeed
- Innovate to Excel
- Perform with Accountability
- Lead with Empathy
- Act with Agility
- Strong Domain Knowledge
- People Management
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