Plan, design, and ensure that all the required Quality Management Systems (QMS) at Sanofi, Goa site are in-place, in-use and in-line with the current regulatory (i.e.
local and relevant International regulatory), cGMP and Sanofi Global Directives requirements thereby assuring the quality of the product manufactured and packed at the site.
Quality Management Systems (QMS) Design & implement the QMS at the site in adherence to the current regulatory (i.e.
local and relevant international regulatory), cGMP and Sanofi Global Directives requirements.
Plan and provide adequate resources to execute the quality operations.
Approval of specification, test procedure, Standard Operating Procedure (SOP), Batch Manufacturing Record (BMR), Batch Packaging Record (BPR), Master Formula Record (MFR) & other documents and any amendments thereof, as may be required for conformance with cGMP.
Integration of SOPs into the QMS designed to prevent and correct quality problems and non-GMP compliant behavior.
Review and approval of Site Master File (SMF).
Qualification & approval of contract testing / manufacturing third parties and Approval of Technical Agreements and Quality Agreements.
Ensuring appropriate Validation & Qualification levels as per the cGMP / GLP requirements.
Review and approval Of Validation Master Plan, Qualification / Validation protocols and reports.
Participate in various forums at the site and contribute for system implementation in various activities at the site.
Facilitate product transfers and new product launches at the site.
2.
Quality Assurance Establish and monitor system for review of Batch documentation and release or rejection of a batch.
Ensure that all necessary sampling & testing of starting materials, intermediates, finished products, validation samples, is carried out as per applicable procedures & / or sampling plans.
Handling of Market Complaints (Product Technical Complaints - PTCs) and identification of appropriate corrective & preventive actions (CAPA).
Investigation of deviations, Out of specification (OOS) / Out of trend (OOT) results and identification of appropriate corrective & preventive actions (CAPA) AND Effectivity checks.
Change control evaluation and approval or rejection.
Management of Self Inspections and Internal Audits to ensure conformance with cGMP and related regulatory requirements.
Approve annual Product Quality Reviews.
Batch Rework/Reprocessing Approval.
Key Responsibilities Handle voluntary / mandatory product recalls as a local leader.
Ensure implementation of appropriate Quality Risk Management tools and the system.
Ensure the system for Retention of documents & records as per applicable cGMP requirements.
Ensure implementation of the system for the management of computerized systems.
3.Quality Control (QC):
Establish and monitor system for testing and release / rejection of raw material (RM), packaging material (PM) and intermediates and finished goods FG.
Provision, maintenance and management of adequate resources including testing facilities.
Provide technical support, adequate resources and guidance to associates inmatter pertaining to quality of RM / PM I Intermediates FG / Stability samples/validation samples.
Establish & monitor the system for appropriate Stability study & microbiological testing at site.
Approve method validation / verification documents.
Approval of Artworks of Packaging Materials:
Approve artworks designed and developed by Packaging Material Testing and Development (PMTD) Laboratory to ensure that it meets the regulatory requirements and are aesthetically suitable.
5.
Training:
Ensure that the system for management of GMP training is in-place and in-use.
Ensure that required initial & continuing training of Department personnel is carried out & adapted according to the need.
6.
Regulatory Compliance Review and approval of Master manufacturing and Laboratory Control documents required for registration purpose.
Authorised signatory for Sanofi India Limited, Goa site for state FDA purpose.
Fulfil requirements of licenses from local FDA, co-ordinate various local and international regulatory inspections.
Ensure that the GMP certifications, product permissions received at site are Appropriately maintained.
7.
Health, Safety and Environment:
Ensure sufficient resources in Quality Control and Quality Assurance for safe working condition.
Ensure implementation of HSE policy through incorporation in SOP's Implement ISO 14001 standards with respect to laboratories.
Ensure safety risk assessment for laboratory instrument and & activities.
Ensure that the department activities are carried out as per the standard operating Procedures that are in line with the Sanofi Quality and HSE directives and Guidelines.
Ensure people safety at all times, thereby ensuring ZERO Injuries to our employees.
8.
Other:
Carrying out any other assignments or projects as per the need to meet the organizational objectives and priorities.
Development of the site quality team by cascading the departmental objectives and setting individual targets for direct reports.
Ensure Succession Ian for key roles.
Identifying and correcting unsafe conditions or behaviours and other potentially hazardous situations and re or-ting the same promptly.
Consolidate Quality Key Performance Indicators (KPls) and monthly reports to senior management.
Prepare, monitor and control the revenue and capital budget of the quality department.
Ensure that the systems are in-use to manage the eTools at site (e.g.
Phenix & Geode, Idea, SAP Athena, etc.)
Included HSE componets in JD 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.
Summary Location:
Verna Type:
Full time