Syngene Ltd QA Team Member Vacancy 2021 – Apply Online
Syngene Ltd invites candidates with a bachelor’s degree in pharmacy for the post of executive. B Pharma job opening 2021, B Pharma job opening 2021, Junior Team Member – QA job vacancy 2021, Interested candidates check out all the details on our website Rasayanika.com
Job Title: Junior Team Member – QA (61079)
Location: Goa India
Division Quality
Department Quality
Employment Type Permanent
Education Qualification B. Pharma/ M.Sc
Relevant Work Experience 2 years of experience in the quality assurance department
Competencies/Skills
- Communication Skills (clarity of thought, comprehension)
- Likely potential for growth
- Job / Product / Technical Knowledge / Pharma domain knowledge
- Presentation & Interpersonal skills (If applicable)
- Managerial or People Management skills
- Safety awareness (If applicable)
- Relevance of Previous Experience
- Comprehension, Analytical & Problem solving abilities
- Productivity & Result Orientation (If applicable)
- Attitude
- Qualification fitment
- Sales drive (If applicable)
- Personality traits (Individualistic / Team player, Outspoken, Maturity level etc.)
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
I. Collate, review and provide required work plans on received deficiencies to HO in
order to respond to regulatory authorities in a timely mannerII. Review Master Validation protocol and report for timely execution of validation batches and timely submission of documents in order to respond 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 the site for execution of batches as per customer requirement
V. Receive and distribute approval certificate, dossiers (TDP & RAP), and development report at the unit for execution of new products smoothly
VI. Coordinate with auditors and site teams for regulatory and customer inspection/ audit at the site to meet regulatory expectations and acquire GMP approvals
VII. Prepare the 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 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
IX. Drive continuous improvement initiatives in CQA to facilitate adherence to cGMP
X. 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
XI. Support in CDSCO and state FDA inspection to be GMP compliant and getting product license, FDA stall approvals by ensuring cross-functional interaction
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