Job Overview
- Date Posted27/01/2023
- Location (State / UT)
- Expiration date--
- Experience2 Years
- GenderAny
- Desired QualificationBachelor Degree, Master’s Degree
- Salary in (₹)Negotiable
Job Description
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 with 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 the 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