Job Purpose

Monitor and execute the production activities in an area during the shift by maintaining cGMP and safety norms to achieve production targets

Accountabilities

I. Execute production activities in a shift by managing available resources to achieve production target
II. Maintain standard process parameters as per BMRs and other supporting documents for achieving production target and maintaining quality
III. Prepare manufacturing records and update online documentation to meet production and cGMP requirements
IV. Follow safe work processes and ensure safety appliances are utilised during production activities in shifts to create a safe working environment
V. Execute production activities in a shift by managing available resources to achieve production target

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 manner
II. Review Master Validation protocol and report for timely execution of validation batches and timely submission of documents in order to response 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 site for execution of batches as per customer requirement
V. Receive and distribute approval certificate, dossiers (TDP & RAP) and development report at unit for execution of new products smoothly
VI. Coordinate with auditors and site teams for regulatory and customer inspection/ audit at site to meet regulatory expectation and acquire GMP approvals
VII. 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
VIII. 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
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 licence, FDA stall approvals by ensuring cross functional interaction

Job Purpose

Execute analysis of allocated samples and Produce reliable and reproducible results in order to ensure their compliance to the microbiological quality parameters and predefined specifications and standards

Accountabilities

I. Analyse and review samples based on work allocation to meet the service level agreement
II. Report errors, abnormal observations, non-compliances related to procedures, equipment and instruments, and deliver results promptly to facilitate timely action and avoid delay in releases
III. Document entries, raw data and findings concomitantly in relevant test data sheets so as to facilitate the lab QA to review the reports and avoid missed entries
IV. Evaluate & document Instrument / equipment break down and suggest mechanisms to avoid the same

Job Purpose

Monitor and execute the packing activities in a shift by maintaining cGMP and safety norms to achieve production targets

Accountabilities

I. Execute shift packing activity by managing available resources and reduces micro stoppage of machine to achieve shift target
II. Review documentation related to packing activity and monitor standard packing parameters as per BPR to meet regulatory requirement
III. Prepare manufacturing records and update online documentation to meet production and cGMP requirement
IV. Monitor adherence to safety guidelines in the block during a shift for packing activities to create safe working environment
V. Provide training to staff & workmen for packing activity by regular interactions with them to get quality product
VI. Provide new ideas and simplify processes to reduce process cycle time and achieve new targets

Junior Officer – Production

Junior Team Member – QA

Junior Team Member – Microbiology 

Junior Officer – Packing