Care has served as the cornerstone on which Cipla has constructed its organisation. Our overarching goal has always been to care for life, and we still do so today. With the same goal in mind, we expanded our footprint to 80+ countries, offering more than 1,500 medications in 50+ dosage forms across diverse therapeutic categories. We are expanding our footprint in the important markets of India, South Africa, the United States, and other growing economies in order to make healthcare more accessible globally.
Post Name: Team Member QA
Division: Quality
Department: Quality
Employment Type: Permanent
Job Purpose
Review the compliance level of site for deficiency response, prepare master validation protocol and report as per company 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 response for deficiencies
III. Review annual product quality review report at units for completeness and data correctness to ensure compliance to cGMP requirements and audit readiness
IV. Review, upkeep and issue regulated market technical agreements at site for execution of batches as per customer requirement
V. Receive and distribute approval certificate, dossiers (TDP & RAP) and development report at unit for execution of new products smoothly
VI. Coordinate with auditors and site teams for regulatory and customer inspection/ audit at site to meet regulatory expectation and acquire GMP approvals
VII. Prepare final draft of compliance to audit observation and check whether it is in line with cGMP requirement to avoid regulatory action and continual improvements
VIII. Collect, compile and review raw data and finalise 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 licence, FDA stall approvals by ensuring cross functional interaction
Education Qualification: B. Pharma/ M. Sc.
Relevant Work Experience: 3-4 Years of experience in Quality Assurance Department
Competencies/Skills
1. Communication Skills (clarity of thought, comprehension)
2. Likely potential for growth
3. Job / Product / Technical Knowledge / Pharma domain knowledge
4. Presentation & Interpersonal skills (If applicable)
5. Managerial or People Management skills
6. Safety awareness (If applicable)
7. Relevance of Previous Experience
8. Comprehension, Analytical & Problem solving abilities
9. Productivity & Result Orientation (If applicable)
10. Attitude
11. Qualification fitment
12. Sales drive (If applicable)
13. Personality traits (Individualistic / Team player, Out spoken, Maturity level etc.)
Job Location: Goa
