Manager - Quality Assurance

Job title: Manager Quality Assurance

• Location Mumbai

• % Remote working and % of travel expected – 20% travel, working as per HO Mumbai policy

• Job type: Permanent

About the job

Our Team:

This is external manufacturing dept. engaged in Quality compliance at contract manufacturing organization (CMO). Candidate has to ensure implementation and monitoring of the quality management systems at Sanofi EM sites as per cGMP and Sanofi GQD requirements in order to ensure the quality of products delivered to market with optimum resource utilization.  To ensure local and country of export regulatory compliance requirements and provide stability data for products, manufactured, released and distributed for sale by External Mfg. To ensure proper analysis and documentation and product releases. Support Project management team for implementation of new products.  (External Manufacturing)

Actively manage the assigned CMOs to ensure supply of products at the right time and quantity, with acceptable quality, in full regulatory compliance.

Main responsibilities:

CGMP compliance at CMO & Release of products

• Ensure all Operational aspects of the manufacturing of pharmaceutical products at identified CMOs comply with the requirements of the Sanofi Quality directives and meet all relevant cGMP & regulatory requirements.

• Monitor and Ensure that all drug products are timely released in accordance with the registered specifications and are released to the market in accordance with local regulations.

• Ensure that coordinated contact is maintained with other functions within Sanofi namely Purchasing, Legal, Supply Chain, Drug Regulatory Affairs, and Marketing etc for timely operational compliance and release of product.

Quality Agreements

• Maintain a valid QA agreement which is in line with the Global template clearly defining cGMP roles and responsibilities between Sanofi and the CMO’s, for applicable products.

•  Perform the required periodic review and negotiation with CMO and make recommendations for amendments to the agreement based on identified needs and issues.

Audit Management  

• Responsible for ensuring that Quality Audits of CMOs and suppliers of raw and packing materials are carried out as per allocation according to the defined frequencies and Annual calendar.

• All critical and major findings to be discussed with Quality Head and Head QO on timely manner for the appropriate action plan. 

• Ensure closure for corrective and preventive action plans for audit findings and timely updated in QualiPSO.

Product Technical Complaints

• Actively participate in the Product Technical complaint investigation with the CMO for the investigation of product technical complaints.

• Identification of appropriate CAPA and implemented timely manner at CMO.

• Closely coordinate with Hub for timely closer of PTC within timeline.

Quality Management System Compliance

• Manage all Quality Issues (Deviations, complaints, OOS, recalls, counterfeit, stability failures, critical risk etc.) according to the Quality Management system defined as per EM SOP and Sanofi Global directives.

• Provide timely information to QMS on above quality event for registration in appropriate system e.g. QualiPSO.

• Actively participate in evaluation and defining CAPA / action plan/Investigations and agree with plan and its implementation time lines.

• Execute/Implement at CMO the task assigned in QualiPSO for relevant quality event, CC, investigation, CAPA, action item etc.

• Ensure investigations/actions items / CAPA’s are correctly executed timely manner at CMO site as well as EM India organization as applicable.

• Ensure verification of implementation of identified CAPA at CMO during site Quality review visits.   

• Ensure the compliance of the product through testing as per specification, change management, stability studies, deviation and investigation, OOS and market complaint systems.

• Responsible for assessing Quality trends through APQR’s and driving Continuous improvement for processes and product quality performance. To ensure validations, qualifications at CMO site.

• Ensure all APQR are received timely manner as per APQR calendar and are assed with in timeline.

• Ensure all APQR are meeting requirement as per Sanofi SOP and Global directive.

CMO Quality reviews

• Ensure all Quality reviews are conducted for the CMO’s assigned as per the SQR calendar.

• Quality review visit reports are prepared timely manner and are discussed with Head QA for the observations and actions taken during the Site Quality reviews.

• Ensure the Product approved Dossier and Pharmacopeia are appropriately implemented for the products manufactured at assigned CMO.

• Identify the gaps and draw an action plan by discussion with head QA. Ensure implementation of action plan timely manner.

Regulatory Authorities Inspection

• Ensure to maintain Quality and regulatory compliance of CMO allocated by On-Site Quality review as per planner.

• Ensure audit readiness at CMO for regulatory audits at CMO.

• Ensuring timely completion of the compliance to the local and export regulatory audits of the contract manufacturing sites.

New Drug Product –Quality Evaluation

• Evaluate the new drug product sites for new product evaluation and follow up compliance to ensure the timelines of product launches.

• Review of product-quality dossiers and conclude on outcome and approval.

• Identify the gaps and draw an action plan by coordinating with CMO. Ensure implementation of action plan.

Project Management   

• To lead, participate, support the projects of technology transfer/Continuous Improvement projects for new products or existing products identified and allocated as per project Management.

•  Ensure compliance to Sanofi Technology Transfer standards, procedures and applicable cGMP and regulatory registration (dossier) as required.

• Ensure smooth analytical and manufacturing transfer through close working with transferring site and receiving site.

• Ensure for timely feedback and updation on status of projects allocated to project management team.  

• Conduct due diligence or cGMP audit of new site as a prospective sub ­ contractor, evaluate & approve new product dossiers.

Perform Quality Risk assessment

• To continuously evaluate the quality risks and escalate all potential quality issues and risks  and initiate all actions as defined.

• To perform Quality Risk assessment as necessary for critical quality issues.

• Conduct investigation for the critical risk and timely feedback.

• Conduct the CMO risk ranking as per the frequency for the assigned CMO’s. Timely discuss and align the Action plan for the improvement of CMO risk ranking with Head QA.

Other Responsibilities 

• Ensure all product related documents are collected and stored in Sanofi database to maintain complete product history.

• Reporting of KPI and submission of monthly report timely before 2nd of every month.

• Any other assignment allocated by manager depending upon the requirement.

About you

• Experience: Minimum 10-15 year in Pharma formulations

• Soft skills: Communication, Analytical and strong logical orientation, Decision making, Networking

• Technical skills: Knowledge in quality function, work experience in Sterile products and non-sterile products manufacturing and compliance, Knowledge of Indian and International cGMP, regulatory and company’s Global requirement in pharmaceutical Operations, Knowledge about QA, QC & Manufacturing

• Education: B pharm, M.Pharm / M.S. / M.Sc

• Languages: English, Hindi,

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