Team Member

2 weeks ago

Goa, India Cipla Full time

**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
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**:

- 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**:

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