B.Pharma, M.Sc Vacancy at Cipla: Check More Details

Overview:

Cipla is hiring an experienced Team Member – QA at their Sikkim location.

The complete details of this job are as follows:

Roles and Responsibilities:

Accountabilities

• Collate, review and provide required work plans on received deficiencies to HO in order to respond to regulatory authorities in a timely manner
• Review Master Validation protocol and report for timely execution of validation batches and timely submission of documents in order to response for deficiencies
• Review annual product quality review report at units for completeness and data correctness to ensure compliance to cGMP requirements and audit readiness
• Review, upkeep and issue regulated market technical agreements at site for execution of batches as per customer requirement
• Receive and distribute approval certificate, dossiers (TDP & RAP) and development report at unit for execution of new products smoothly
• Coordinate with auditors and site teams for regulatory and customer inspection/ audit at site to meet regulatory expectation and acquire GMP approvals
• 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
• 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
• Drive continuous improvement initiatives in CQA to facilitate adherence to cGMP
• 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
• 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

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