Assistant Mangaer -QA

Job description

CGMP compliance at API Mfg CMO site & 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 Substances 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 drug Substances. Perform the required periodic review and negotiation with CMO and make recommendations for amendments to the agreement based on identified needs and issues.

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 QMS central cell for timely closer of PTC with in 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 e.g. 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 / 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.

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.

Project Management

·  To 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.

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 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.

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

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.