R&D Senior Quality Associate

We have an urgent opening for one of the Leading FMCG Organization for the Profile of "R&D Senior Quality Associate" Based at Delhi NCR.

Roles & Responsibility :

- Ensures that the local Quality Management System meets current regulatory requirements and internal standards as defined within the Business Management System (BMS) across all R&D sites.

- Ensures policies are implemented within local SOPs within the local QMS as appropriate, site specific.

- Ensures that there is an appropriate and systematic approach in place for the quality approval of documents such as batch manufacturing records, Standard Operating Procedures, deviations, change controls, risk evaluation and management documents, validation documents and other quality related records as defined within the local QMS

- Develops and manages an annual internal audit program for the sites to verify and improve the effectiveness of the of the operational quality management system

- Ensures that there is a system in place that manages the assessment, audit and approval of external GMP suppliers and service providers used during the development process

- Maintains an approved supplier list for the facility locally or as part of a global system and ensures Technical Agreements are in place and are reviewed as per internal requirements

- Maintains and communicates performance of the QMS via the agreed Quality Key Performance Indicators - to ensure deviation, change controls and out of specifications are handled to a high standard in appropriate timeframes

- Schedules and leads the Management review for the sites.

- Manages the quality release function supporting Consumer trials locally and as appropriate. Ensures that the systems that in place locally are aligned with the R&D quality release systems in Hull.

- Manages the annual GMP quality improvement action plan for the facility and ensures quality improvement initiatives are assessed and implemented promptly and effectively

- Ensures a system is in place to deliver GMP Induction and refresher training and that training on key quality systems and principles is also provided to the R&D Teams locally

- With the R&D Category Teams, ensures that the technical transfer of projects are completed and consistent with satisfactory handover to manufacturing and launch to the market

- Provides quality input and approval of software validation, including major systems impacting R&D

- Ensures that key quality documents are kept up to date for example Site Master File, IMP Manufacturing Authorisation as appropriate

- Responsible for the development of his/her team members to enable them to achieve their full potential

- Proactively monitors and ensures the facility has plans in place to respond to changes in guidance and legislation issued by Regulatory Authorities

- Leads the preparation for and actions arising from inspections by Regulatory Authorities/Notified Bodies.

- Degree in a relevant scientific discipline e.g. Pharmacy, Biology or Chemistry

- Qualified or in training to be an EU QP, eligible to assess and release IMPs for Clinical studies - UK based role requirement

- Trained and experienced Lead Auditor

Ritu Agarwal

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