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.

Skill, Education, Experience

Education:

• Bachelor's or Master's degree in Pharmacy, Chemistry, or a related scientific discipline.

Experience:

• 10 - 13 years of progressive experience in pharmaceutical quality assurance, preferably in TPM or contract manufacturing environments.
• In-depth knowledge ofSchedule M, GMP,ICH guidelines,regulatory requirements, andquality management systems.
• Strong analytical, communication, and leadership skills with the ability to influence cross-functional teams and TPM's.
• Experience in handling audits, investigations, and QRM is highly desirable.

Skill:

• Attention to Detail: Critical for reviewing documentation, artworks, and compliance data.
• Analytical Thinking: Required for investigations, risk assessments, and CAPA closure.
• Communication Skills: To coordinate with TPMs, internal teams, and global stakeholders.
• Time Management: For handling multiple reviews, approvals, and project tasks efficiently.
• Adaptability: To manage evolving regulatory requirements and internal process changes.
• Excellent problem-solving skills.
• Ability to handle multiple projects and changing priorities
• Excellent communication skills