- Company Name
- Radiant Systems Inc
- Job Title
- Quality Specialist
- Job Description
-
**Job Title:** Quality Specialist – Qualified Person (QP)
**Role Summary:**
Lead final batch certification processes in a modern pharmaceutical manufacturing environment, ensuring all released products meet cGMP standards and all applicable regulatory, licensing, and technical agreement requirements across EU, USA, and other global markets.
**Expectations:**
* Deliver timely, compliant batch releases in alignment with commercial schedules.
* Maintain high standards of quality, safety, cost-effectiveness, and customer service.
* Serve as the primary QP contact for regulatory inspections, audits, and product certification.
* Promptly communicate and address any deviations or changes to manufacturing or QC processes.
**Key Responsibilities:**
1. Perform final QP batch certification and release in accordance with manufacturer’s licence, marketing authorisations, ANDAs, technical agreements, CE certification, and relevant national regulations.
2. Verify that all batch documentation, validation records, and testing data satisfy the requirements of regulatory authorities.
3. Review, approve, and certify batches against scheduled shipment plans, ensuring no gaps in compliance.
4. Validate and confirm that all manufacturing and testing processes, including sampling, inspection, and testing, are properly controlled and documented.
5. Coordinate and verify that planned or unplanned changes and deviations are supported by evidence and reported through established systems.
6. Conduct or oversee audits, self‑inspections, and spot checks with experienced staff to reinforce data integrity and process reliability.
7. Escalate any issues that could compromise product compliance, patient safety, or regulatory standing.
**Required Skills:**
* Strong communication, influencing, and teamwork abilities.
* Demonstrated leadership in quality management within pharmaceutical manufacturing.
* Proficiency in data analysis, problem‑solving, and risk assessment.
* Ability to interpret and apply regulatory guidelines (e.g., EU GMP, FDA, EMA, Russia, Brazil, Canada).
* Commitment to continuous improvement and adherence to cGMP principles.
**Required Education & Certifications:**
* Degree (or equivalent) in a scientific discipline (Pharmacy, Chemistry, Biology, etc.).
* Membership or active standing with an appropriate professional body (e.g., IFQM, IQS, PAP).
* Registered Qualified Person (QP) designation recognized by the relevant licensing authority.
* Significant experience (5+ years) in a senior quality role, preferably as a QP or quality leader in a modern pharma manufacturing setting.