Primary Function/Primary Goals/Objectives:

  • Responsible for establishing, managing and implementing Quality audits including internal and supplier audits.
  • Responsible for managing the supplier quality program.
  • Delivers effective training and awareness programs.
  • Identifies record based risks and remediation strategies through regular program compliance monitoring and reporting.
  • Manage regulatory audits as well as ensure site is compliance to all applicable regulatory requirements.
  • Directs the efforts of others in the achievement of the strategic and operational objectives of the group.
  • Manages the hiring, staffing and maintenance of a diverse and effective workforce.
  • Responsible for career development/ planning, performance and pay discussions of team members.
  • Provides managerial leadership, coaching/ feedback and development for direct reports and business partners.
  • Develops, oversees and reports on quality assurance metrics.
  • Works with cross-functional teams to identify cause, track progress and drive resolution of quality issues.
  • Analyzes production limitations and standards.
  • Responsible for internal and external audit program including trending of data.
  • Responsible for the QA related activities for New product introduction.
  • Recommends revision of specifications when indicated.
  • Formulates or assists in formulating quality control policies and procedures.
  • Designated as Quality Manager for ISO/ IEC 17025 to ensure that the Laboratory Quality Management System is established, implemented and maintained in conformance with applicable regulatory and ISO/ IEC 17025 Standard.

Major Responsibilities:

  • To ensure all quality systems are in compliance with Abbott’s corporate and division policy, procedures, applicable regulatory and standard.
  • Responsible for document control and certifications (product quality related).
  • Applies advanced knowledge of technical/ administrative skills to leverage the skills of others.
  • To ensure all document change packages are processed timely and accurately.
  • To conduct internal and external audits and maintained the audits schedule.
  • Responsible for compliance activities in the plant.
  • Responsible for SAP changes and verification of recipes, inspection plan, etc.
  • Develops an understanding of internal operations and how related teams interact to achieve results.
  • Work is guided by operational and project objectives.
  • Improves process efficiencies in support of objectives.
  • Uses a variety of data analysis tools and methodologies.
  • Applies independent judgment to solve systemic problems.
  • Recommends actions and regularly exercises discretion with regards to key business processes within the team.
  • Plans and oversees the daily activities of a team.
  • Promotes collaboration and accountability to meet team goals.
  • Maintains internal and/ or external customer relationships.
  • Frequently interacts with subordinate supervisors and functional peer groups.
  • Resolves problems requiring broad-based analysis.
  • Presents problem analysis and recommends solutions in a creative and logical manner.


  • Degree in Science or Engineering
  • Atleast 3 – 6 years of experience in Quality, Compliance and Audit in a pharmaceutical or healthcare manufacturing environment
  • Knowledge in ISO9001 and FSSC 22000 will be an advantage

You can apply to this job and others using your online resume. Click the link below to submit your online resume and email your application to this employer.