Sr. Quality Coordinator

Support the manufacture Pharma Products under GMP conditions

• Implement Material Release Program
• Approve release or rejection of raw materials, intermediates, packaging, and labeling materials.
• Release or reject all APIs
• Release or reject intermediates for use outside the control of the manufacturing company.
• Review completed batch production and laboratory control records of critical process steps.
• Certify that materials are appropriately tested, and the results are reported before release of the API for distribution.
• Certify that there is stability data to support retest or expiry dates and storage conditions on APIs and/or intermediates, where appropriate.
• Implement quality related production support activities.
• Review maser production instructions.
• Approve or review all procedures affecting the quality of intermediates or APIs
• Prepare, review, approve, and distribute the instructions for the production of intermediates or APIs according to written procedures.
• Audit production of APIs and, when appropriate, intermediates for compliance with pre-approved instructions.
• Review all production batch records and ensure that these are completed and signed.
• Verify that all production deviations are reported and evaluated and that critical deviations are investigated and the conclusions are recorded.
• Verify that production facilities are clean and, when appropriate, disinfected.
• Insure that the necessary calibrations are performed, and records kept.
• Insure that the premises and equipment are maintained, and records kept.
• Review completed batch production and laboratory control records of critical process steps below release of the API for distribution.
• Issue and reconcile labels and seals for GMP production.
• Maintain GMP training program.
• Maintain pest control program.
• Generate COAs for GMP shipments.
• Certify investigation of discrepancies and failures.
• Verify that critical deviations are investigated and resolved
• Verify that quality-related complaints are investigated and resolved.
• Implement Quality Assurance audit activities.
• Perform Internal audits (self-inspections)
• Audit intermediate, API contract manufacturers and raw material vendors.

Customer Support

• Support (investigation and corrective actions) customer complaints.
• Support customer audits (scheduling, hosting) audit reports/responses.

Continuous Improvement

• Maintain the site CAPA process for quality matters.
• Develop and implement work plan to reduce rejection rates of products and improve the product quality.

Implement Safety and Health Activities

• Supports and/or organizes involvement of employees setting up and reviewing SHE plans and requirements, procedures and instructions.
• Acts in such a way that the organization will learn from its incidents. Incidents will be investigated possible improvements (and incidents) are reported and the risks of the work are assessed regularly/routinely.
• Make sure that all procedures and instructions for the job are workable and followed.
• Supports and enforces the policy of reporting incidents and possible SHE incidents and improvement possibilities and checks that the work is routinely risk assessed.

Education and Experience

• Min. of five (5) years’ experience in FDA regulated pharmaceutical industry is essential OR
• Two-year degree (Associates) college curriculum, major concentration in chemistry or related science discipline and a minimum of three (3) years’ experience in FDA regulated pharmaceutical industry is desired OR
• Four-year degree (Bachelor) college curriculum with a major concentration in chemistry or related science discipline and a minimum of one (1) years’ experience in FDA regulated pharmaceutical industry is desired.

Specific Functional Competency Requirements

• Demonstrate knowledge of international GMP regulations and forthcoming changes to regulations and pharmacopeia.
• Demonstrate knowledge of ISO regulations (ISO 9001) or current regulations.
• Build collaboration with Manufacturing and Maintenance to ensure GMP compliance.
• Anticipate customer/regulatory expectations and address proactively.
• Continuously simplify work processes while maintaining compliance.
• Maintain and foster a strong sense of urgency to meet or exceed site goals.
• Maintain and develop two-way communication for goals, tasks, issues and project progress.