Sr. Quality Coordinator - (21000011)Description
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.
Qualifications
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.
Primary Location: US-SC-Orangeburg Work Locations: Orangeburg 725 Cannon Bridge Road Orangeburg 29116 Job: Manufacturing & EHSQ Organization: NA Region (US) Schedule: Regular Shift: Standard Employee Status: Individual Contributor Job Type: Full-time Job Level: Day Job