Junior Team Member - QA

Division

Quality

Department

Quality

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

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 response for deficienciesIII. Review annual product quality review report at units for completeness and data correctness to ensure compliance to cGMP requirements and audit readinessIV. Review, upkeep and issue regulated market technical agreements at site for execution of batches as per customer requirementV. Receive and distribute approval certificate, dossiers (TDP & RAP) and development report at unit for execution of new products smoothlyVI. Coordinate with auditors and site teams for regulatory and customer inspection/ audit at site to meet regulatory expectation and acquire GMP approvalsVII. Prepare final draft of compliance to audit observation and check whether it is in line with cGMP requirement to avoid regulatory action and continual improvementsVIII. 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 planningIX. Drive continuous improvement initiatives in CQA to facilitate adherence to cGMPX. 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 requirementsXI. 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

Collaborate to SucceedInnovate to ExcelPerform with AccountabilityLead with EmpathyAct with AgilityStrong Domain KnowledgePeople Management

Job Location

Patalganga

Shift Hours