The jobholder ( QRM) acts as a member of our third party operations supplier relationship team & positively influences the new product sourcing & supply processes by ensuring that all quality risks are clearly evaluated & articulated & mitigated.
Jobholder closely interacts with other departments such as Procurement group, Supply chain and planning, Technical services, regulatory etc. and provides complete support to the SRTfrom quality perspective in various projects, initiatives and forums.
The jobholder will be responsible for Quality management of finished dose forms associated with, which are manufactured at assigned Contract Manufacturing Organizations (CMO) and at Key suppliers within the scope of TPO Organisation.
2. Job Purpose:
To manage the TPO Quality system requirements at the aligned Contract manufacturing Organisation (CMO) / at Key suppliers and to ensure the identified products are transferred to the identified CMO, manufactured and supplied successfully in accordance with quality standards and in compliance with marketing authorization of specific market/s.
This activity has the following aspects –
– Responsible to follow the Quality Management System of TPO organisation, which is relevant to job function.
– Quality assurance and compliance management of products at aligned CMO / Key suppliers.
– Ensure smooth analytical technology transfer through close working with transferring site laboratory and receiving site laboratory. This includes coordination activities related to; review/ approval (as applicable) of transfer protocol, assessment of laboratory readiness, sharing knowledge of methods, standards and test samples etc.
– Constant monitoring and improving the overall cGMP compliance at aligned CMO / key supplier sites.
– Provide Quality support to improvement, investigation, trouble shooting, and cost saving initiations.
Essential Duties & Responsibilities:
1)Document Management: Preparation and review of the QMS procedures required for the Quality operations. Maintenance and archival of the documents as per the required retention times.
2)Quality Due-Diligence: Support in evaluation of CMO’s quality systems and compliance, e.g. Review of CMOs quality evaluation of preliminary questionnaire, assessment, apply internal / external intelligence to evaluate and facilitate the site due-diligence meeting / audit etc. and provide input to the management.After satisfactory outcome of Quality Due diligence, facilitate the 3rd Party audit for qualification audit of CMO.
3)Establishment of Quality Agreement (QTA) between receiving site & CMO: Support the QTA establishment together with the QTA group and facilitate negotiations if applicable and ensure valid QTA in place and updated whenever there is a change in relevant sections of QTA.
4)Pre-Approval Inspection (PAI): Participate as a team member when appropriate in developing CMO and getting ready for PAI.
5)Analytical Technology Transfer: Facilitate in transferring registration and relevant Quality document to CMO & formally document the transfer.
Ensure compliance to Technology Transfer standards, procedures and applicable cGMP and regulatory registration (dossier) as required.
Ensure smooth analytical technology transfer through close working with transferring site laboratory and receiving site laboratory.
This includes coordination activities related to; review and approval of transfer protocol, assessment of site laboratory readiness, sharing of methods, standards, test samples etc as applicable.
6)Annual Product Review / Periodic Product Review:
Ensure the CMOs have procedures and systems in place describing the preparation, approval, and report and archiving of product reviews.
Track and ensure APQR/PQR provided to review team in time and its completeness.
Track any CAPA’s resulting from a CMO’s product review through completion.
7)Change Management: Evaluate and approve all change requests received from CMOs and assure that change is managed in line with standards, QTA and regulatory registration dossiers.
8)Complaint Management: Ensure product quality complaints are investigated, documented and Corrective and Preventive Actions (CAPAs) are implemented by CMOs.
9)Quality Council Meetings with CMO- s: Organize Quality Council Meeting, at defined intervals based on risk with CMOs as part of Business Review Meetings.
Collate key quality performance metrics agreed with CMOs & trends.
Collect status of Quality improvement actions (derived from audits, deviation & complaint investigations, risk assessments etc).
Provide compliance status with QTA requirements.
Salary: ₹ Not Disclosed by Recruiter
Industry: Healthcare & Medicine
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