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.
- 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
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