Syngene Ltd QA Team Member Vacancy 2021 - Apply Online

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 manner

II. 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

Apply Online

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