QA & Reglatory Consultant

JOB TITLE

QA & Reglatory Consultant - 7 Moonths

THE COMPANY

One of the top Pharma Companies in the world. The organisation is seeking a talented indivdual to join them. This is an excellent opportunity for someone looking to progress their career in Pharmaceuticals working within a global company.

LOCATION

Zug, Switzerland

SALARY
Up to 60 CHF Per Hour

OVERALL CANDIDATE CONTEMPENCIES FOR THE ROLE

Provides support in the management, deployment and implementation of initiatives defined under implementation of the new regulation for the medical devices

• Collaborate with Regulatory OTC - in order to collect the data from the dossiers in regards of the medical devices (for combination products)
• Collaborate with internal stakeholders (Source QA & Make & Source) the follow up of original communication performed with the EM in regards of suppliers for medical devices
• Follow up and collect from EMs, the questionnaire sent out in relation with medical devices suppliers
• Collect samples of the combination products from EMs and consolidate the overview in regards of the artwork information and type of medical device used versus dossier
• Perform a review of the questionnaires and consolidate an overview
• Collaborate with EM Make - in order to build the logistic flow for all impacted products under MDR
• Connect with UDI work stream in regards of the combination products list (to confirm sale forecast)
• Support additional requests which might come from other WS
• Support the activity to place QRA between medical devices suppliers - identified as Legal manufactures and the company (if applicable)
• Support the preparation of the regular updates within the organization
• Collect from medical devices suppliers the documentation (as defined)
• Support QMS workstream - review potential procedures which would need to be updated due to MDR implementation

REQUIREMENTS

• BA degree in Life Sciences, Pharmacy or Engineering
• General knowledge of global regulatory requirements (e.g. ISO 13485, 21 CFR Part 820)
• Excellent communication skills, verbal and written in English
• Proficiency in MS office
• 1-2 years of experience in a multinational environment in the MD / Med-tech industry.
• Ability to multitask efficiently.

ABOUT i-PHARM CONSULTING

i-Pharm Consulting is a specialist Recruitment Company servicing the Pharmaceutical industry in the UK and Europe. We provide both permanent and contract staff to a wide range of Pharmaceutical, Medical Device, Biotechnology and Contract Research Organisations (CROs). i-Pharm has specific expertise in Clinical Research, Medical Affairs, Regulatory Affairs, Pharmacovigilance, Quality Assurance and Bioinformatics.

www.i-pharmconsulting.com

TO APPLY:
If you would like to discuss this vacancy further, please call the Global Strategic Delivery Consultant Billy Twomey on +44 (0)20 3189 0460. If this role is not suitable, Billyis also available to discuss other possible positions or answer any general questions regarding your career and the current market.

KEY WORDS
Sr Director / Payroll / Global Payroll / Oracle / Sr Director Payroll / Cambridge / UK / England / Pharma / Pharmaceuticals / Biotech / Biology / Admin / Finance / Accounting / London / Oracle AWR / Admin / London / Uxbridge /