Category

Description

Key responsibilities are listed below and not limited to
o Manager processes to always be inspection ready (FDA and external audit)
o Ensures that the NCRs and Specification Deviations are managed as per established processes and corrective actions are implemented in a timely manner
o Provide guidance and training to respective employees (including manufacturing, supply chain, commercial etc.) in various quality system areas

COMPLIANCE
Ensure that the Quality of products (Conventional RRP) and internal processes complies with internal and external requirements, standards and policies and maintain relevant certifications.
Define, deploy and maintain quality planning strategiesactivities within manufacturing center while assuring system compliance.
QUALITY SYSTEM MANAGEMENT
Lead and ensure the implementation and maintenance of the QMS for both products in liaison with training department. Act as owner for the local QMS process management related systems, reviewapprove QMS procedures, work instructions and other quality documents escalated to his level.
PROJECT MANAGEMENT
Supervise the deployment of new Quality projects with the aim to improve overall factory performance and foster the implementation of global initiatives.
AUDIT
Ensure audit readiness including the planning and implementation of inspectionsaudits assuring risk-free evidence package for regulatory inspection whenever applicable, as well as related remediation activities. Support the coordination of audit program schedule. Develop and maintain an internal auditor pool and transfer knowledge of this process.
MANAGEMENT REVIEW
Lead the management review process and assist the local management to ensure that the management systems remain suitable, effective and aligned with the factory objectives.
LEADERSHIP
Manage and develop a motivated and skilled team to ensure performance levels, professional development and achievement of objectives, in respect of PMI Competences Model and Total Quality Philosophy. Develop and drive the execution of a skill matrix and training path for each role.
Prepare and seek management approval for department budget based on factory objectives to ensure optimal allocation of resources, adequate funding, and compliance with financial practices.
Support OPEN program deployment with Leadership and Lean Thinking.
HEALTH, SAFETY AND ENVIRONMENTAL POLICIES
Promote and apply all rules concerning PMI Quality, environment, health and safety. Report all situations requiring actions in order to minimize or eliminate risks exposure to personnel, company assets and societal impacts and be in line with or ahead of any applicable Law requirements and Company standards.

Ideal candidate would have below qualifications

- CollegeUniversity or Master degree in Biological sciences, Physical sciences, Engineering or equivalent skills through demonstrated experience
- Minimum 3-5 years experience in Quality Assurance in Tobacco, Pharmaceutical
- Strongly preferred experience of hosting external regulatory inspections and audits (FDA and others). Ensures that pre and post-inspection activities are completed including scheduling, record review, training, logistics, etc. Prepares responses to audit nonconformities for review by management.
- Advanced knowledge of QA standards (ISO 9001, ICH)
- Knowledge on pharmaceutical andor medical device industry regulations would be considered as an addtional asset
- Project Management and Change Management skills
Industry
Consumer Goods Tobacco
Employment Type
Full-time

Job Functions
Quality Assurance

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