Clintec are actively recruiting for Quality Control Specialist II to join our expanding global company in Switzerland. This is a site-based position in Schachen, near Lucerne. It is a part-time, Fixed Term Contract opportunity. By working for Clintec you can further your career in a dynamic, fast-paced environment and you can be assured of rewarding benefits.
The Quality Manager (QM) is supporting the Quality Unit of our sponsor the Quality Responsible Person (QRP) as registered contact to the Swiss Health Authorities for quality issues and his Deputy (QRP).
The QM works together with the QRP and the Deputy QRP to maintain an open and transparent relationship with the Health Agency Swissmedic, the Regional Health Inspectorate, and the Cantonal Health Authority.
The QM supports the implementation of directives issued by the QRP in GMP/GDP matters in the quality interests of Clintec
The QM supports the QRP in overseeing the quality systems and processes, in accordance with local and international regulations and internal standards.
Supporting the release process of authorized medicinal products and vaccines for the Swiss market:
control of batch certificates and comparison with regulatory requirements (approved release specifications, shelf-life, authorized sites involved in the manufacturing process, further regulatory filings etc.)
record and evaluate results of transport temperature monitoring
report temperature excursions and request disposition statements
check of artwork
Administration and Change Control of an operational pharmaceutical quality assurance system for GxP-critical areas:
life-cycle management, administration and change control of standard operating procedures, work instructions, protocols, flow-charts, controlled job aids, and forms according to approved Master SOPs and valid templates
formal control of documents in review, support of SOP process owners and authors with structural and formatting rules during creation and review of SOPs
implementation of inputs during review of controlled documents
Product Quality Reviews (PQRs):
retrieve and ensure timely review of PQRs for authorized and marketed medicinal products, assure that time-lines for review are respected
file the completed and reviewed PQRs, follow-up delayed PQRs
Product Quality Complaints:
processing of Product Quality Complaints (receipt, classification, forwarding to manufacturer, tracking, feed-back to customers, metrics, periodical evaluations)
timely information of Pharmacovigilance Country Lead in case of suspected AEs in connection with PQCs
Support processing of quality defects and possible notifications to Swissmedic
Support planning and monitoring of general GDP training of employees (initial training, GxP-awareness training)
Prepare check-lists and protocols for annual self-inspection and mock recall
Awareness and implementation of applicable regulations and dissemination to relevant colleagues
Required expertise and core competencies:
Higher education (e.g. Masters degree) in pharmacy, medicine, biology or a comparable discipline
1 to 2 years of experience in Quality Assurance (GMP/GDP) within pharmaceutical industry and local Swiss, European and international GxP regulations would be an asset, however position is also suitable for recent graduates
Excellent analytical and problem solving skills, based on science, data and understanding of regulatory requirements in a complex and evolving environment; ability to apply sound risk management
Fluency in German and English, preferably also French.