Junior Team Member

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 response 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 (TDP & RAP) 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 finalise 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 licence, FDA stall approvals by ensuring cross functional interaction

Education Qualification

B. Pharma/ M.Sc

Relevant Work Experience

2 years of experience in 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, Out spoken, Maturity level etc.)