CIPLA pharma jobs Goa – Junior Team Member – QA

Junior Team Member – QA CIPLA

CIPLA job opportunities for B pharmacy and MSc candidates for Quality Assurance department

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 to 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 expectation 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

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 Location; Goa

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