Job Posting: Junior Team Member – QA (80105)
Job ID: 80105
Posted on: 01/11/2023
Location: India – Sikkim – Rangpo
Introduction:
We are a company dedicated to delivering high-quality products to our customers by ensuring compliance to regulatory guidelines. As a Junior Team Member – QA, you will play a crucial role in reviewing the compliance level of our site, preparing master validation protocols, and contributing to our overall quality policy.
Department: Quality
Division: Quality – Micro
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:
- 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 site: For execution of batches as per customer requirement
- Receive and distribute approval certificate, dossiers 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 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 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 license, FDA stall approvals by ensuring cross-functional interaction
Education Qualification:
B. Pharma/ M.Sc
Relevant Work Experience:
2 years of experience in Microbiology
Competencies/Skills:
- Collaborate to Succeed
- Innovate to Excel
- Perform with Accountability
- Lead with Empathy
- Act with Agility
- Strong Domain Knowledge
- People Management
Keywords: Rangpo, QA, Quality, Microbiology, GMP compliance, regulatory guidelines, continuous improvement. Subscribe to Rasayanika for the latest chemistry and Pharma job openings, follow us on Facebook and Telegram and subscribe to our youtube channel for the latest updates on chemistry and Pharma jobs and much more.
