Abbott Laboratories

<!DOCTYPE html PUBLIC "-//W3C//DTD HTML 4.0 Transitional//EN" "http://www.w3.org/TR/REC-html40/loose.dtd"><html><body> Primary Job Function: <ul><li>Lead and guide the team for LLM Operations and functionality on GMP aspects and Abbott policies and procedures.</li><li>Monitor compliance of Loan license manufacturing sites and TPMs.</li><li>Perform LLM site visits on scheduled basis and ensure compliance of LLM sites to cGMP, Abbott policies and Procedures.</li><li>Ensure Pharmacopoeial compliance of Abbott products manufactured at LLMs.</li><li>Review ongoing stability data and control samples of Abbott products.</li><li>Ensure implementation of Abbott quality audit CAPA & closure at LLMs.</li><li>Ensure timely investigation of the Market complaints within SLA, root cause analysis, CAPA implementation and effectiveness check.</li><li>Coordinate with responsible CFT for NSQ’s, Govt Agency responses.</li><li>Review & assess change controls, deviations, OOS/Failures at LLM sites related to Abbott products.</li><li>Ensure QTA compliance at LLMs and ensure QTAs are in place for all LL/TPMs.</li><li>Monitor and support projects as assigned by the Manager.</li><li>Ensure review and approve documents for tech transfer projects @ TPMs and FLQR review and approval for all projects for existing products and changes.</li><li>Review of change controls and approval for products at TPMs in Abbott system.</li><li>Tech Transfer at TPMs including Analytical method transfer, FLQR (First Lot Quality Review )</li><li>Ensure and review GSR notifications and timely compliance at TPMs impacting Abbott products</li><li>Ensure an effective communication process within cross functional team for execution of Quality projects supporting India Business.</li><li>Ensure compliances related to regulatory changes impacting Abbott products and processes.</li><li>Recruit, mentor, train and develop TPM QA India team members.</li><li>Manage the CFT stakeholders including S& OP meetings, lead from the quality front.</li><li>Ensure Deloitte Compliance across all LL sites including implementation of Abbott’s processes and compliance across all LL sites in coordination with LL site management</li></ul>Data Management           <ul><li>Ensure all TPM and product related database is maintained and achieved for the TPM QA function.</li><li>Customize Quality related procedures and Work instructions for the region as required for local requirement and its periodic review/ updates/ additions of SOPs to continuously improve processes and ensure compliance</li></ul>              Stakeholder Management<ul><li>Set and manage of expectations with stakeholders (Commercial, Planning,  TPMs, MS&T, Regulatory, Labelling w.r.t Quality and Regulatory compliance.</li><li>Support AVD projects for loan license sites and materials for requirement as per Abbott process and policies.</li></ul> Expectations & Skills :<ul><li>Leverage knowledge, people networks inside and outside the company, out of the box thinking to resolve problems impacting Quality and regulatory challenges etc. impacting Abbott business.</li><li>Flexible, proactive and motivated by the opportunity to optimize structures and processes</li><li>Works collaboratively with colleagues to achieve organizational goals</li><li>Ability to adapt in a high pressured an ever-changing business environment</li><li>Ability to constructively cope with conflicts</li><li>Strong and proven analytical, organizational and decision-making skills</li><li>Strategic thinking, result and compliance oriented</li><li>Good interpersonal and communication skills</li><li>Resolution driven with adequate technical expertise</li><li>Ability to work efficiently in complex and deadline-driven operations, not losing focus on accuracy and quality</li><li>Proven track record to set priorities and adapt them accordingly at short notice</li><li>Effectively work on multiple, unrelated projects simultaneously</li><li>Provide expert guidance to team and CFTs on quality aspects and requirements supporting business</li><li>GMP and Regulatory requirement, TPM Management, Due diligence.</li><li>Ability to influence others. Intercultural competence.</li><li>Ability to understand the impact of business development decisions and contractual language on the Operations organization.</li><li>Ability to handle large volumes of confidential information and data and be able to determine how and when to inform upper management on quality related matters. Have a good control on Product database related to Quality.</li></ul>Team Management          <ul><li>Develop a high-performance team by continuous monitoring and provision of guidance to develop the team</li><li>Identify improvement areas and conduct/drive initiatives for training sessions to upskill people to ensure functional knowledge of process.</li></ul> Supervisory/Management Responsibilities:Direct Reports:   - 02Indirect Reports:  - Contingent Workers @ LLMs ( Around 50 for SAP users management) Position Accountability/Scope:<ul><li>Key contact for Quality aspects for Loan License products.</li><li>Support and navigate to CFTs for Quality related matters for impacted products</li><li>Quality Technical Agreements.</li><li>Compliance to Abbott procedures and policies.</li><li>Tech Transfer and FLQR</li><li>Metrics review and management.</li><li>Change Control Management</li><li>Understand the overall Quality policies and EQDs and its implementation in India as per Global procedures.</li><li>Ensure an efficient exchange of information and a close working relationship with the CFTs for regulatory and Pharmacopoeial changes impact ting Abbott products</li><li>Provides guidance to LLM/TPMs for the compliances and investigation support for quality failures like Market compliant investigations, OOS, OOT.</li><li>Establish and maintain an expanded network of contacts to share best practices, expertise related to Quality and Regulatory changes.</li><li>Promote quality and compliance, simplification and standardization in global TPM QA</li></ul>Leadership / Team leading:<ul> <li>Lead cross-functional, key contact for Quality Aspects to support business.</li></ul> Minimum Education:<ul><li>B Pharm /M. Pharm / Master in Science</li><li>Any additional education is an added asset.</li></ul> Minimum Experience/Training Required:<ul><li>12 to 15 years of experience in Quality Control / Quality Assurance,  QMS, R&D QA, TPM Management, Tech Transfer, Dossier review, Due Diligence of products and sites.</li><li>Required to have managed TPM’s in a significant</li></ul> Languages:<ul><li>Proficiency in English</li><li>Other languages are advantageous</li></ul></body></html>

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