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Position Description

Specialist Quality Assurance - Pharmaceutical Environment - Switzerland - Lucerne Location Switzerland - Luzern Job Code 3959 Category Clinical Supplies Apply Now

Specialist Quality Assurance
Temporary contract until end of 2021

Lucerne, Switzerland

 

Are you looking to become a valued member of an award-winning clinical research organisation, with a collective goal of positively improving the health and wellbeing of people? Clintec is looking to expand our Supply Chain Specialist time to join our clients pharmaceutical development and manufacturing site located in Lucerne area.

You will have the opportunity to work dedicated to a world-renowned company, on some of the most prestigious and ground-breaking drug development projects impacting lives all over the world. Every employee strives to find innovative ways to overcome obstacles together, and this team centric ethos is crucial to the continued success of Clintec.

Our management team recognise that every employee is different, so we offer individual training and development plans to suit your goals and expectations. You’ll enjoy a fast-paced and dynamic environment, where we value inclusion and promote teamwork.
 

What we can offer you:
 

• A competitive salary and benefits package; performance related bonus, private healthcare allowance, pension contribution and flexible working options


• 25 days annual leave per year plus 15 days bank holiday entitlement


• Career development/training opportunities and a life-long career with an innovative, forward-thinking clinical research company


• Team focussed social events throughout the year, subsidised food canteen and a high-quality working environment  

 

Qualifications:

• Master's Degree in in pharmacy, medicine, biology or equivalent.


• Minimum of 2-years’ experience in Quality Assurance (GMP/GDP) within the pharmaceutical industry. Please do NOT apply if you don’t have experience in the pharmaceutical sector. We won’t be able to consider your application.


• Documented experience with local Swiss, European and international GxP regulations.


• Experience with quality management tools and/or workflow management tools.


• English and German language – Proficiency at a business level. French knowledge is a plus.


• 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.


• Teamwork, communication and solution-oriented.

 

Responsibilities:

The Based in Lucerne, the Quality Assurance Specialist will support the Quality Responsible Person (QRP) as registered contact to the Swiss Health Authorities for quality issues and his Deputy in maintaining an open and transparent relationship with the Health Agency Swissmedic, the Regional Inspectorate, and the Cantonal Health Authority in all distribution matters in Switzerland.

As a Quality Assurance Specialist, you will support the implementation of directives issued by the Quality Responsible Person in GMP and GDP matters in the quality interests of our Company’s distribution in Switzerland. You will also support the QRP in overseeing the quality systems and processes, in accordance with local and international regulations and internal company standards.

Our Quality Assurance group ensures every single material inside our products is manufactured, processed, tested, packaged, stored and distributed aligned with our incredibly high standards of quality and meets all regulatory requirements. Partnering across our internal manufacturing facilities, external contract manufacturers and suppliers we create an interdependent global manufacturing network committed to deliver a compliant, reliable supply to customers and patients on time, every time, across the globe.

Primary activities include, but are not limited to:

Support 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.


• Artwork checks.


• Process deviations. 
   

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.

 

 

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