Job Description

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 master validation protocol and report within timeline
• Check major observation in other units documents also for improvement of validation documents at site
• Synchronize all units Validation documents for improvement of all units

Review annual product quality review report at units for completeness and data correctness to ensure compliance to cGMP requirements and audit readiness

• Collect APQR timely with units for review
• Review data with supporting documents for data authentication
• Check major observation with other units for improvement of documents at site

Key Accountabilities (2/6)
Review, upkeep and issue regulated market technical agreements at site for execution of batches as per customer requirement

• Review and compile received technical agreements for comments
• Provide guidance for execution of batches and handling events as per customer requirement
• Provide training in department to improve awareness in audit and compliance with licencing department
• Take follow up with HO for providing fresh TA and pending TAs for products

Receive and distribute approval certificate, dossiers (TDP & RAP) and development report at unit for execution of new products smoothly

• Receive and check approval certificate, dossiers (TDP & RAP) and development report for distribution at site
• Update site on receipt of documents for handling execution of customer or market specific batches

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

• Inspect audit prerequisites to support and prepare for external audits
• Coordinate with Units for preliminary draft response and prepare final draft within timeline
• Follow up for closure of compliance commitments
• Provide adequate, errorless and timely compliance to CQA
• Monitor implementation of CAPA derived in compliance by assessing current regulatory requirements and inspecting its effectiveness review
• Prepare and submit EPA annual production application for getting the establishment registration of unit V

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

• Coordinate with units for all the raw data, its review and finalization before submission to corporate
• Prepare pre-inspection compliance report after announcement of MHRA audit

Key Accountabilities (4/6)
Drive continuous improvement initiatives in CQA to facilitate adherence to cGMP

• Review warning letters received by competitors, analyse the current scenario to ascertain gap and prepare an action plan to prevent such an occurrence at site
• Review audit observations received by other Cipla sites, analyse the current scenario to ascertain gap and prepare an action plan to prevent such an occurrence at site
• Participate in internal team for conducting self-inspection, report preparation, submission and compliance review, to evaluate adherence to cGMP
• Prepare and update procedures in line with current GMP requirements

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

• Collect, review and finalize applications for:

• Additional Product
• COPP
• Test License
• Renewal of drugs manufacturing license and WHO GMP certificate
• All certificates for product registration and tender
• Alcohol Quota
• FDA Staff Approval
• Site Layout Approval

• Submit and process above application to FDA (district, state, CDSCO) for time bound receipt of approval
• Communicate with FDA to resolve queries and follow ups to monitor status of application
• Review, maintain and distribute approved certificates to concerned stakeholders at site
• Track the consumption of alcohol quota allotted by state FDA under subsidized scheme as per the plan to manage optimum level of alcohol availability for smooth functioning of site
• Track the status of FDA approved staff at site to adhere to Drug and Cosmetic Act
• Track the status of quantity specific product license to monitor dispatch of such products and renewal of license in compliance to DCGI NOC condition

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

• Inspect audit prerequisites to support and prepare for CDSCO and state FDA audits
• Coordinate with Units for preliminary draft response and prepare final draft within timeline
• Follow up for closure of compliance commitments
• Provide adequate, errorless and timely compliance to CQA
• Monitor implementation of CAPA derived in compliance by assessing current regulatory requirements and inspecting its effectiveness review

Major Challenges

• Delay in receiving data for allotted work plans from units may impact whole process of deficiency response hence to overcome this situation we are in continue follow up with units for timely response
• Major observation handling in validation documents impact on registration batch execution, leading to delay in filing of product hence to overcome this situation we share and resolve each observation
• with units timely with resolving strategy
• Lack of detailed compliance with appropriate root cause from user department. Regular discussion and trainings is provided to unit
• Liaising with Government officials for availability and timely approvals of applications

Key Interactions (1/2)

• SPOCs of process validation at site for timely review of master validation protocol and reports at the time document received for review (once or twice a month)
• SPOCs of APQR at site for timely review of APQR (monthly)
• SPOCs of RA at site for timely receiving of work plan response of deficiencies on (weekly)
• Unit QA heads in reference to audit readiness and preliminary draft response (need basis)
• CQA and A&C team for final draft response review (need basis)

Key Interactions (2/2)

• FDA for processing and approval of application (need basis)

Dimensions (1/2)

• Zero overdue compliance of deficiencies.
• 100% adherence to provided timelines for review of documents timely.
• Track and support in Top 07 projects.
• Timely and errorless review of APQR at site. Review should not exceeding 15 days from schedule.
• Ensure quality score minimum of 90% for each month.
• Timely and errorless preparation of tech transfer summary for site. Data submission to corporate should not go beyond 5th of every month
• Average 30 audits/ year
• 100% adherence to timeline of compliance for various regulatory and customer audits.
• No disruption is supply chain because of GMP approvals, product deficiency and product license
• For FDA:

• Approximately 150 additional product license
• 36 test license
• 40 certificates
• 290 COPP

5 staff approvals
Dimensions (2/2)
Key Decisions (1/2)

• Review observation provided for correctness and improvement of master validation protocol and report documents (To Unit QA)
• List of pending technical agreements with requirement of fresh TA to HO for regular execution of customer products.
• Review observation provided for correctness and improvement of APQRs and FDA product license applications at site (To unit QA)
• Recommend to update correct data provided for deficiency response (To HO)

Process of identifying root cause for the observation in various inspection and audit (to CFT)
Key Decisions (2/2)
Education Qualification

• B. Pharma/ M.Sc. with minimum three/ four year of experience in quality assurance department

Licensing and registration (0-2 years)
Relevant Work Experience
Sound knowledge of cGMPs and regulatory guidelines and basic knowledge of computer system