Junior Team Member – QA | Cipla Ltd | Rangpo – Sikkim

Job Purpose

Review the compliance level of the site for deficiency response, prepare master validation protocol and report as per company quality policy and applicable regulatory guidelines

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 respond 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 the site for execution of batches as per customer requirement
• Receive and distribute approval certificates, dossiers (TDP & RAP), and development reports at the unit for the execution of new products smoothly
• Coordinate with auditors and site teams for regulatory and customer inspection/ audit at the site to meet regulatory expectations and acquire GMP approvals
• Prepare the final draft of compliance to audit observation and check whether it is in line with cGMP requirements to avoid regulatory action and continual improvements
• 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
• Drive continuous improvement initiatives in CQA to facilitate adherence to cGMP
• Execute on-time and errorless submissions by reviewing product licenses, 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 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 of a Pharmaceutical Organization