Quality Systems Specialist
An opportunity has arisen for a Quality Systems Specialist to support the implementation and maintenance of quality systems in both the Drug Substance and Drug Product facilities within a leading Biopharma Multinational.
Key Responsibilities:
* Provide leadership and guidance on validation standards required for Process, Cleaning, Water, and Equipment.
* Serve as the principle quality contact for all quality assessments of material control strategies associated with change requests for processing and analytical changes.
* Oversee laboratory QA activities.
* Manage the site inventory of quality agreements to ensure timely execution of quality agreements for all required relationships.
* Create, review, and approve site quality documentation, including supplier change evaluation documentation.
* Investigate supplier and customer complaints.
* Maintain filing and license requirements, and conduct follow-ups on regulatory requests.
* Review and verify documentation for submission to regulatory authorities, such as Pharm-CMC or other requesters.
* Support the internal GMP walk-down and scheduled audits program.
Qualifications and Experience:
* Minimum of a degree or post-graduate qualification in a Science, Pharmacy, or Engineering field.
* 3+ years of relevant experience within the pharma/biotech industry.
* Strong communication skills, both written and oral.
* Pro-active approach, planning, and scheduling experience.
* Customer service skills and interpersonal skills.
* Proficiency in Quality Systems, QA, Pharmaceutical, and Biotech principles.