**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 of **Schedule M** , **GMP** , **ICH guidelines** , **regulatory requirements** , and **quality 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 An Equal Opportunity Employer Abbot welcomes and encourages diversity in our workforce. We provide reasonable accommodation to qualified individuals with disabilities. To request accommodation, please call 224-667-4913 or email corpjat@abbott.com