Senior Manager - Quality Relationship Manager

Konnect HR
  • Mumbai
  • Confidential
  • 15-20 years
  • Views
  • 04 Apr 2018

  • Production/ Manufacturing/ Engineering

  • Pharmaceuticals/ Life Sciences/ Clinical Research
Job Description

Job Purpose: To manage the TPO Quality system requirements at the alignedContract 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 theQuality 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 ataligned CMO / key supplier sites. Provide Quality support to improvement, investigation, trouble shooting, and cost saving initiations. Travel Requirements About 40 - 50 % travel is required 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. 1. Input to Business Review, S&OP Meetings & Participation in SRTs:Provide QA inputs to meetings for example: Quality KPIs andperformance, Audit outcomes, major quality events / concerns, etc.Represent the Quality Aspects of the CMO during SRT meetings 2.Periodic Quality KPI &Reports of CMO: Monitor the KPIs and provide a regular compliance report including CMOs quality issues to the line management. 3.Quality Oversight at CMO- s: Constant monitoring and improving the overall cGMP compliance of CMOs through structured visits to CMO sites. 4.Stability Management: Verify that any required stability study planned by the CMO comply with requirements, International guidelines and regulatory registrations (dossiers). Alert relevant receiving sites immediately as they become aware of any out of specification results or negative trend as part of quality oversight. 5.CMO Batch Document review and provision to receiving sites for market release: Review the following documents (for compliance) provided by CMOs if applicable (but not limited to) and provide to Receiving site to facilitate release to market: Batch manufacturing and packing records & associated documents / records (as applicable). A COA as agreed in the format A Certificate of Manufacturing/cGMP Compliance (COC)as agreed in the format. Any other documentation as applicable and agreed in the QTA. 6.Deviation / Investigation Management: As outlined in QTAs with CMOs review and assess the deviations /investigations and approve / provide to receiving sites as applicable. 7.Issue Management (NTM &GNTM) & Recall: Serve as a member of the NTM /GNTM meetings and will act as prime contact with CMOs during the process.Also issue NTM and co-ordinate all activities involving the CMOs and remediate the issues. Also shall support receiving sites as appropriate. 8.Audit Management & Periodic Quality Risk Assessment: Provide appropriate input to Audit group and ensure execution of the routine QA audit and where necessary, For-Cause Audits.Follow up any corrective and preventive action plans at CMOs and ensure its closure adequately and in timely manner. Perform a Quality Risk assessment on periodic basis and when the audit resulted with critical observation. 9.Regulatory Authorities Inspection:Support CMOs during regulatory agency inspections (FDA, MHRA, etc.) when appropriate and, in agreement with CMO QTA. Track implementation of relevant Corrective Action/Preventive Action (CAPA) plans adequatelyby using an appropriate system. 10.Support to Initiatives: Provide Quality support to any improvement initiatives, trouble shooting, and cost saving initiations, etc. 11.Supplier Exit or Change of Supply: Coordinate QA aspects associated with withdrawal of a CMO or termination with various aspects of supply from a CMO:Lead the implementation of an exit or change plan (From quality perspective) through Change management process. 12.Any other duties as requested by the supervisor. Position Requirements Education Required B. Pharm, / M. Pharm / M.Sc. (Science). Education Preferred Pharmaceutical Sciences Experience Required - Knowledge of cGMP, Quality Systems and the pharmaceutical manufacturing, supply chain environment. - Knowledge on the local Law of land and License to operate. - Knowledge on Compliance Standards and Regulation as applicable to the market. - Experience of handling Operational Quality, QA/QC exposure and External / Contract manufacturing sites. Experience Preferred - Knowledge and working experience with USFDA / MHRA approved sites. - Specialized or Technical Knowledge Licenses, Certifications needed As applicable to law of land. Competencies & Skills: Please list five or six areas of competencies below that are necessary for the incumbent to do this position and that distinguish it from others similar to it. Competencies & Skills Details Problem Solving & Decision Making Makes timely, informed decisions that take into account the facts, goals, constraints and risks. Good analytical thinking and attention to details to analyse and solve the problem. Accountability & Dependability Takes personal responsibility for the quality and timeliness of work and achieves results with little oversight. Adaptability & Flexibility Adapts to changing business needs, conditions and work responsibilities and flexible thinking. Self-Management Manages own time, priorities and resources to achieve goals.Ability to work independently under his/her own initiative Leadership Promotes organizational mission and goals, and shows the way to achieve them. - Communication - Negotiating / influencing skills Good communication skills - Verbal & written, this role being deals with external CMOs. Strong negotiating / influencing skills to deal with external CMOs and getting the activities completed as per expectations.

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