Manager TPM QA

MAIN PURPOSE OF ROLE

Job Responsibilities

• Third Party Manufacturing (TPM) Site Compliance :
• Perform regular and ad-hoc visits to TPM facilities across the West Zone to evaluate compliance with current Good Manufacturing Practices (cGMP) primarily Revised Schedule M, Abbott's internal quality standards, and applicable regulatory guidelines.
• Identify non-conformities, process inefficiencies, and documentation gaps during site inspections.
• Collaborate with TPM quality teams to develop robust corrective and preventive action (CAPA) plans.
• Monitor CAPA implementation timelines and effectiveness through follow-up visits and reviews.
• Audit CAPA Oversight :
• Review audit findings from TPM sites and ensure timely development and implementation of CAPAs.
• Track CAPA progress and verify effectiveness through follow-up assessments.
• Maintain accurate CAPA documentation in line with Abbott's quality systems and regulatory standards.
• Coordinate with TPMs and internal teams to resolve recurring issues and drive systemic improvements.
• Support audit readiness by reviewing CAPA histories and preparing TPMs for inspections.
• Use digital tools (e.g., SolTraqs) to create Auditee records, manage CAPA workflows and ensure timely updates whenever necessary.
• Market Complaint Investigation :
• Receive and document product complaints from the market in compliance systems.
• Lead or support investigations to identify root causes using structured problem-solving tools.
• Coordinate with TPMs and internal teams to define and implement CAPAs.
• Ensure timely resolution and closure of complaints with proper documentation.
• Analyze complaint trends to identify recurring issues and recommend preventive actions.
• Support Abbott audits by maintaining accurate complaint records and summaries.
• Assess product impact and recommend actions such as holds or recalls if necessary.
• QMS :
• Quality Risk Assessment :
• Conduct risk assessments for identified issues, deviations, or changes in manufacturing processes.
• Recommend mitigation strategies and escalate critical risks to senior management when necessary.
• Change Control, Deviation, OOS Management :
• Evaluate change control proposals and deviation / OOS reports from TPMs.
• Ensure changes are scientifically justified, risk-assessed, and compliant with regulatory and internal standards.
• Trackwise Task Management :
• Initiate Exception Reports, Planned deviations
• Manage CAPA tasks associated with ER, PD, Market Complaints and on time closure.
• Tracking and closure of ageing documents impacting metrics.
• Approve and manage artwork-related tasks within the Trackwise system
• Stability Data & Control Sample Review :
• Analyze stability study data and control samples to ensure product quality over shelf life.
• Provide recommendations for shelf life extensions or product improvements based on data trends.
• Performance Scorecard Tracking :
• Maintain and update performance scorecards for TPMs in the West Zone.
• Use scorecards to monitor quality metrics, identify trends, and drive continuous improvement initiatives.
• Compendial Change Compliance :
• Track updates in pharmacopeial standards and ensure timely implementation across relevant products.
• Liaise with regulatory and formulation teams to assess impact and ensure compliance.
• Shelf Life Extension Projects :
• Coordinate with formulation, regulatory, and quality teams to evaluate and implement shelf life extension strategies.
• Ensure documentation and regulatory submissions are completed accurately.
• Artwork Review & Approval :
• Review and approve product artworks for new and existing products, ensuring compliance with regulatory and branding guidelines.
• Collaborate with PLM, I&D, and global teams to manage artwork lifecycle and changes.
• Export Barcode & Global Artwork Management :
• Review and approve export barcodes and artworks received from global teams for India region products.
• Ensure accuracy and compliance with international packaging and labeling standards.
• Ensure timely execution and documentation of all assigned tasks.
• Project Support & Cross-Functional Collaboration :
• Support quality-related projects assigned by the Manager, including process improvements, system upgrades, and regulatory initiatives.
• Collaborate with internal and external stakeholders to ensure project goals are met efficiently.
• New Product Introduction / Technology Transfer
• Knowledge Transfer : Receive and assimilate new products approved by Innovation & Development (I&D) or New Product Introduction (NPI) teams as part of the pre-commercialization process at TPM.
• Product Lifecycle Understanding : Possess comprehensive knowledge of the product lifecycle—from development through to commercialization.
• Post-Approval Change Management : Effectively manage and implement changes to products after regulatory or internal approval.

Education

Skill, Education, Experience

Experience

Skill

Skills Required

trackwise , Change Control, Risk Assessment, Analytical Thinking, Attention To Detail