Cipla is a leading global pharmaceutical company trusted by healthcare professionals and patients across the world since 1935. A compassionate approach to healthcare that goes beyond the pursuit of profit and growth has been the force impelling Cipla’s history over the years. Our credo and our purpose of ‘Caring for Life’ continues to guide our actions towards our people and the planet for creating a sustainable future. Cipla today has presence in 80+ countries, providing over 1,500 products across various therapeutic categories in 50+ dosage forms.
Vacancy details:
- Department:Team Member – QA
- Experience:3-4 years
- Qualification: B. Pharma/ M.Sc
- Salary:₹ Not Disclosed by Recruiter
Job Description : Greeting from Intas Pharmaceutical Limited!!!!
Important Details :
- Location:Rangpo-Sikkim
- Post of date:18/03/2024
- Selection Process: The selection will be on the basis of Interview.
- Mode of Interview: Face to face
- Interview Rounds of Interview: HR
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
Relevant Work Experience
3-4 years of experience in 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
ABAC
