Company: Edelway Switzerland AG
Location: Basel area
Closing Date: 29 Dec 16
Type: Full Time
Salary (£): Negotiable
Edelway is a pan-european Pharma Consultancy. One of our best clients, a global, pharmaceutical company based in Basel Area is currently looking for experienced QA Specialist.
- Providing training to site personnel and contractors on GMP and the Quality System procedures.
- Performing Internal Audits and Data Audits, as needed.
- Document creation and review, including Standard Operating Procedures, protocols, and reports.
- Reviewing Manufacturing batch records and completing required documentation for batch disposition.
- Providing on the floor support to Manufacturing.
- Capturing and reporting metrics around Quality System and Batch Record review turnaround times and closure/approval times.
- Inputting information from the Quality Systems into electronic databases and generating reports from these systems.
- Working with all departments to ensure timely completion of Deviations, CAPA, Change Controls, Investigations, and Environmental Excursions.
- Representing Quality Assurance at various project and technical meetings, as needed.
- Interacts professionally with company management, internal departments and other sites to effectively implement and maintain Quality Systems.
- Reviews and approves Corrective and Preventative Actions (CAPA); includes tracking, follow-up, and reporting/trending and evaluating CAPA for effectiveness.
- Reviews and assesses deviations; includes performing risk assessments, participating in root cause analysis investigations, tracking, follow-up and reporting/trending.
- Works closely with Manufacturing and Quality Control to resolve open issues resulting from record reviews, on the floor walk through activities of the facility, and deviation issues.
- Makes recommendation to Quality Assurance Management for the release of product based on Quality Assurance record review and approval.
- Reviews manufacturing and support records to certify compliance with specifications and procedures.
- The QA Specialist III contributes to the completion of milestones associated with specific projects and supports ongoing quality assurance responsibilities in support of the manufacture, testing, and release of product. May determine methods and procedures on new assignments and may provide guidance to other lower-level personnel. Performs all responsibilities in accordance with company policies, procedures, and federal regulations.
- Performs all responsibilities in accordance with company policies, procedures, federal regulations and safety requirements.
- Minimum of 5-8 years GMP related experience in biopharmaceutical / pharmaceutical or related industry with 3 years direct Quality experience. Excellent written and verbal communication and negotiating skills.
- Ability to prioritize daily activities in order to meet internal and external customer needs in a fast-paced environment.
- Ability to monitor and report on assigned tasks, goals and objectives.
- Ability to work on Quality projects where analysis of data requires evaluation of identifiable factors.
- BS/BA degree in Chemistry, Biology or related field
If this sounds like your next challenge please send us your CV at “email@example.com“ or contact us at +34 93 018 5722.