Team Member - QA

Division

Department

Sub Department 1

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

Key Accountabilities (1 / 6)

Collate, review and provide required work plans on received deficiencies to HO in order to respond to regulatory authorities in a timely manner

• Collect data from all SPOCs with respect to received work plan for review
• Escalate any delays in receiving response from unit with respect to work plan
• Review of collected data for work plan fulfilment
• Send data to HO for compilation of deficiency response
• Take follow up with HO to receive updated dossier for product updates

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

Key Accountabilities (2 / 6)

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

Key Accountabilities (3 / 6)

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

Key Accountabilities (4 / 6)

Drive continuous improvement initiatives in CQA to facilitate adherence to cGMP

Key Accountabilities (5 / 6)

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

Key Accountabilities (6 / 6)

Support in CDSCO and state FDA inspection to be GMP compliant and getting product licence, FDA stall approvals by ensuring cross functional interaction

Major Challenges

Key Interactions (1 / 2)

Key Interactions (2 / 2)

Dimensions (1 / 2)

5 staff approvals

Dimensions (2 / 2)

Key Decisions (1 / 2)

Process of identifying root cause for the observation in various inspection and audit (to CFT)

Key Decisions (2 / 2)

Education Qualification

Licensing and registration (0-2 years)

Relevant Work Experience

Sound knowledge of cGMPs and regulatory guidelines and basic knowledge of computer system

Skills Required

Cgmp, regulatory guidelines , Capa