Production Compliance Specialist

1. JOB OBJECTIVES

Participate in production planning and organization to ensure smooth running of operations.

Manage the various production files and pay particular attention to compliance with documentation, manufacturing processes, and health and safety standards.

2. PRIMARY FUNCTIONS

• Support the supervisors in implementing initiatives to improve and optimize processes, documentation and equipment (CAPA, projects, etc.).
• Participate in improving and optimizing production processes and performing tasks related to quality systems (CAPA, CCF, etc.) to support sterile operations.
• Consult with key stakeholders to implement their requirements and floor needs.
• Ensure that all corrective measures are implemented and followed up on as required in a timely manner.
• Maintain a proactive presence on the production floor to ensure that records and other documentation comply with established procedures and good manufacturing and documentation practices.
• Collaborate with support departments to plan and coordinate maintenance, validation, and training activities and assign the personnel/equipment necessary for their execution.
• May be called upon to initiate non-compliance procedures when required and take the necessary actions to minimize the impact on product quality.
• Participate in investigations as needed.
• Perform any other related tasks deemed relevant to the position.

3. EXPERIENCE REQUIREMENT AND APTITUDES

• Bachelor's degree in Science or any other relevant experience.
• Minimum of 5 years of experience in the pharmaceutical industry, including at least 3 years in the manufacture of injectable products.
• Solid knowledge and understanding of injectable product manufacturing processes and Good Manufacturing and Documentation Practices.
• Leadership, initiative, resourcefulness, and autonomy.
• Organizational skills and a focus on quality and results.
• Ability to manage priorities and work under pressure with tight deadlines and frequent changes in priorities.
• Problem-solving and interpersonal communication skills.
• Analytical and synthesis skills and good judgment.
• Team spirit and ability to work in multidisciplinary teams.