Cmo Quality Associate

2 weeks ago

Mumbai, India Merck KGaA Darmstadt Germany Full time

Work Your Magic with us

Ready to explore, break barriers, and discover more? We know you've got big plans - so do we Our colleagues across the globe love innovating with science and technology to enrich people's lives with our solutions in Healthcare, Life Science, and Electronics. Together, we dream big and are passionate about caring for our rich mix of people, customers, patients, and planet. That's why we are always looking for curious minds that see themselves imagining the unimageable with us.

Specific Job Description
- Responsible for deployment & effective implementation of Quality Management System for External Supply Quality, Healthcare Business, India in line with Global Healthcare Quality Standards & procedures.
- This position supports to internal stakeholders to provide sustaining quality and compliance for implementation of Quality management system in Healthcare business, India.

**Key Accountabilities**
- Responsible for ensuring timely completion of gap assessments between local Quality standards and global MBQ standards released from time to time, documentation of quality risk assessment for identified gaps if any, defining the action plan for local implementation wherever required.
- Preparation/updating the local SOPs to align with the Global Quality standards. Ensuring that the training is pushed to concern stakeholders for updated/new standards.
- Ensuring continuous monitoring & improvement of Deviation Management System through Quality Assessment, investigation of deviations, review & approval of CAPA plans, ensuring timely implementation of CAPAs, closing and monitoring of deviations for products under responsibility of ESQ, India to determine recurrence and detect potential trends.
- Providing support in review & approval of complaint investigations received from CMOs, corrective actions, preventive actions, closing and monitoring of the same in close co-ordination with respective SPOCs or his/her delegates as a QA responsible.
- Monitoring & tracking of the change control proposals raised in Trackwise System.
- Review & approval of change control proposals process the change control proposals raised in Track Wise System as a QA CC CO-Ordinator. Release the report related to change control management on regular intervals as a part of the management review of the quality system.
- Handle the trouble shooting occur in the Track wise system.
- To Organise the training programs related to Trackwise system (Complaint Management, Change Control Management, CAPA Management, Deviation Management & Audit Management) for new users and collect & send the details to Trackwise. Administration for creation, updating & cancellation of the Trackwise accounts.
- Support to management of Product Alert related to products manufactured at CMO sites in India.
- Monitoring and Reporting of Quality Index for Healthcare, India.
- Review & approval of products artworks for compliance as per Quality requirement.
- Drive timely periodic quality review and risk assessment of CMO management and ensures the compliance and appropriate corrective & preventive actions are identified and implemented.
- Responsible for development and maintenance of Quality Agreements.
- Responsible for availability and compliance of Product Quality Reviews.
- Evaluates and presents monthly CMO quality metrics for management oversight review.
- Providing support to review of all quality records & documents (BMR, BPR, Validation protocols & reports, Stability protocol etc.) related to CMO according to CMO Governance, respective quality system, Quality Agreement and ensure the compliance (i.e. but not limited to Deviation, Change Control, Investigation, etc).
- To perform additional tasks as assigned by Head of ESQ India

**What we offer**:We are curious minds that come from a broad range of backgrounds, perspectives, and life experiences. We celebrate all dimensions of diversity and believe that it drives excellence and innovation, strengthening our ability to lead in science and technology. We are committed to creating access and opportunities for all to develop and grow at your own pace. Join us in building a culture of inclusion and belonging that impacts millions and empowers everyone to work their magic and champion human progress

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