Overview

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.

Requirements:

  • 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

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