Location
Mumbai | India
Job description
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 CMOs, 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 performing quality audits of CMOs and suppliers of raw and packing materials and ensuring that Quality Audits 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
- Prepare Audit report within timeline and upload in Phenix and Ensure closure for corrective and preventive action plans for audit findings and timely updated in Phenix
Product Technical Complaints :
- Timely coordinate and communicate the PTC to CMO s for investigation
- Actively participate in the Product Technical complaint investigation with the CMO for the investigation of product technical complaints
- Closely work with the central cell for identification of appropriate CAPA and implemented timely manner at CMO
- Closely coordinate with central cell 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.
- Provides timely information to center cell QMS on above quality event for registration in appropriate system eg Phenix.
- Actively participates in evaluation and defining CAPA/ action plan / Investigations and agrees with plan and its implementation time lines with center cell QMS.
- Executes/Implements at CMO the task assigned in Phenix for relevant quality event, CC, investigation, CAPA, action item etc
- Ensure investigations/actions items / CAPAs 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 APQRs 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.
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
- Closely work with central QMS cell to Perform Quality Risk assessment as necessary for critical quality issues
- Conduct investigation for the critical risk and timely feedback to Central cell
- Conduct the CMO risk ranking as per the frequency for the assigned CMOs
- 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
- Artwork review and approval from QA perspective
- Any other assignment allocated by manager depending upon the requirement
Health Safety and Environment:
- Monitor the HSE activities (including audits) across the EM-INDIA CMO s as per SANOFI HSE requirements & ensure CMO meets the SANOFI needs
- CMO categorization based on previous and ongoing audit findings
- Preparation of HSE audit schedule for CMOs
- Co-ordination with auditing company and CMO for HSE audit, CAPA implementation and verification Participate in HSE audits as an observer as and when required
- Root cause analysis and CAPA verification for any business interruption due to HSE issues at CMOs Executive summary readiness for all CMOs audited
- Provide support to Corporate HSE Management as and when required
Track and Trace:
- To implement track and Trace system at CMOs Ensure DGFT and country specific requirements are followed for all export products under EM India
- To monitor the Operational activities of Serialization for export products under EM-INDIA perimeter
Deputation of responsibility Acts as Deputy to Peer Quality manager as and when assigned or in absence of Quality manager in the section and vice versa
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