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Senior Manager- Quality Assurance

Senior Manager- Quality Assurance

ConfidentialMumbai, India
2 days ago
Job description

JOB DESCRIPTION :

Primary Job Function :

  • Lead and guide the team for LLM Operations and functionality on GMP aspects and Abbott policies and procedures.
  • Monitor compliance of Loan license manufacturing sites and TPMs.
  • Perform LLM site visits on scheduled basis and ensure compliance of LLM sites to cGMP, Abbott policies and Procedures.
  • Ensure Pharmacopoeial compliance of Abbott products manufactured at LLMs.
  • Review ongoing stability data and control samples of Abbott products.
  • Ensure implementation of Abbott quality audit CAPA & closure at LLMs.
  • Ensure timely investigation of the Market complaints within SLA, root cause analysis, CAPA implementation and effectiveness check.
  • Coordinate with responsible CFT for NSQ's, Govt Agency responses.
  • Review & assess change controls, deviations, OOS / Failures at LLM sites related to Abbott products.
  • Ensure QTA compliance at LLMs and ensure QTAs are in place for all LL / TPMs.
  • Monitor and support projects as assigned by the Manager.
  • Ensure review and approve documents for tech transfer projects @ TPMs and FLQR review and approval for all projects for existing products and changes.
  • Review of change controls and approval for products at TPMs in Abbott system.
  • Tech Transfer at TPMs including Analytical method transfer, FLQR (First Lot Quality Review )
  • Ensure and review GSR notifications and timely compliance at TPMs impacting Abbott products
  • Ensure an effective communication process within cross functional team for execution of Quality projects supporting India Business.
  • Ensure compliances related to regulatory changes impacting Abbott products and processes.
  • Recruit, mentor, train and develop TPM QA India team members.
  • Manage the CFT stakeholders including S& OP meetings, lead from the quality front.
  • 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

Data Management

  • Ensure all TPM and product related database is maintained and achieved for the TPM QA function.
  • 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

    • Stakeholder Management

  • Set and manage of expectations with stakeholders (Commercial, Planning, TPMs, MS&T, Regulatory, Labelling w.r.t Quality and Regulatory compliance.
  • Support AVD projects for loan license sites and materials for requirement as per Abbott process and policies.

    • Expectations & Skills :

  • 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.
  • Flexible, proactive and motivated by the opportunity to optimize structures and processes
  • Works collaboratively with colleagues to achieve organizational goals
  • Ability to adapt in a high pressured an ever-changing business environment
  • Ability to constructively cope with conflicts
  • Strong and proven analytical, organizational and decision-making skills
  • Strategic thinking, result and compliance oriented
  • Good interpersonal and communication skills
  • Resolution driven with adequate technical expertise
  • Ability to work efficiently in complex and deadline-driven operations, not losing focus on accuracy and quality
  • Proven track record to set priorities and adapt them accordingly at short notice
  • Effectively work on multiple, unrelated projects simultaneously
  • Provide expert guidance to team and CFTs on quality aspects and requirements supporting business
  • GMP and Regulatory requirement, TPM Management, Due diligence.
  • Ability to influence others. Intercultural competence.
  • Ability to understand the impact of business development decisions and contractual language on the Operations organization.
  • 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.

    • Team Management

  • Develop a high-performance team by continuous monitoring and provision of guidance to develop the team
  • Identify improvement areas and conduct / drive initiatives for training sessions to upskill people to ensure functional knowledge of process.

    • Supervisory / Management Responsibilities :

    Direct Reports : - 02

    Indirect Reports : - Contingent Workers @ LLMs ( Around 50 for SAP users management)

    Position Accountability / Scope :

  • Key contact for Quality aspects for Loan License products.
  • Support and navigate to CFTs for Quality related matters for impacted products
  • Quality Technical Agreements.
  • Compliance to Abbott procedures and policies.
  • Tech Transfer and FLQR
  • Metrics review and management.
  • Change Control Management
  • Understand the overall Quality policies and EQDs and its implementation in India as per Global procedures.
  • Ensure an efficient exchange of information and a close working relationship with the CFTs for regulatory and Pharmacopoeial changes impact ting Abbott products
  • Provides guidance to LLM / TPMs for the compliances and investigation support for quality failures like Market compliant investigations, OOS, OOT.
  • Establish and maintain an expanded network of contacts to share best practices, expertise related to Quality and Regulatory changes.
  • Promote quality and compliance, simplification and standardization in global TPM QA

    • Leadership / Team leading :

  • Lead cross-functional, key contact for Quality Aspects to support business.

    • Minimum Education :

  • B Pharm / M. Pharm / Master in Science
  • Any additional education is an added asset.

    • Minimum Experience / Training Required :

  • 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.
  • Required to have managed TPM's in a significant

    • Languages :

  • Proficiency in English
  • Other languages are advantageous

    • The base pay for this position is

    N / A

    In specific locations, the pay range may vary from the range posted.

    JOB FAMILY : Operations Quality

    DIVISION :

    EPD Established Pharma

    LOCATION :

    India Mumbai : BKC Building

    ADDITIONAL LOCATIONS :

    WORK SHIFT :

    Standard

    TRAVEL : Not specified

    MEDICAL SURVEILLANCE :

    Not Applicable

    SIGNIFICANT WORK ACTIVITIES :

    Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

    Skills Required

    Quality Control, Quality Assurance, Gmp, Qms, Due Diligence

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