Pharmaceutical Quality Specialist
3 days ago
We are PCI Pharma Services, a leading global CDMO dedicated to the healthcare industry. Our mission is to deliver life-changing therapies by bridging the gap between pharmaceutical companies and their patients.
Job Description:We are seeking an experienced Pharmaceutical Quality Specialist to join our team. This role will be responsible for ensuring that all quality-related tasks associated with customer accounts are completed to the desired standard and on time.
Responsibilities:The successful candidate will have the following responsibilities:
- Quality Task Completion: Ensuring receiving reports, batch records, and QP release requests are completed on time and documents shared with customers as applicable.
- Issue Resolution: Processing customer-related information through applicable workstreams once data is verified, identifying any issues during customer receipt, batch record review, or QP release, and ensuring appropriate resolution and tracking/trending.
- Investigation Support: Assisting with investigations of customer-related quality issues/deviations/issues and drafting investigation reports on time to customers.
- Event Disposition: Disposition of events and non-conformances as applicable.
- Metrics Reporting: Completing customer-specific action items from audits, investigations (e.g., CAPAs), and reporting/customer metrics/key performance indicators (KPIs).
- Presentation Skills: Presenting quality information to customers during calls or Business Review Meetings (BRMs) and attending conference calls and customer meetings.
- Subject Matter Expertise: Providing subject matter expert input to investigations/complaints and other quality-related information.
- Training and Development: Mentoring QA Team members and other departmental personnel.
- Knowledge Management: Knowledge of and adherence to all relevant PCI procedures and GMP rules/guidelines.
- Process Improvement: Developing, updating, and implementing procedural changes throughout Quality Management Systems across sites.
To be successful in this role, you will need:
- Education: A University degree in a scientific or health-based field.
- Experience: Ideally, experience in the pharmaceutical industry or related field with good knowledge of European GMP/GDP legislation and guidelines (or ISO quality management system standards).
- Skills: Proficiency with MS Office Suite programs and ideally experience in hosting/participating in audits.
We offer a competitive salary of $100,000 - $120,000 per year, depending on experience, plus benefits including medical, dental, and vision insurance, 401(k) plan, and paid time off.
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