Pharmiweb ChannelsAll | PharmaCo | Clinical Research | R&D/BioTech | Sales/Mktg | Healthcare | Recruitment | Pharmacy | Medical Comms

Pharmiweb.com RSS Feed Pharmiweb.com RSS Feeds

Job Details

QA Manager CMO EU

Company: ProClinical Ltd
Location: Haarlemmermeer
Reference: QA.BK.15354
Closing Date: 22 Feb 18
Type: Permanent
Salary (£): Negotiable
Benefits:

Job Summary:

ProClinical is working with a client that has recently acquired a biologics division to add to their vast product portfolio. They are a Global Pharmaceutical company and looking for dedicated support to establish oversight in the EU CMO activities. QA Manager CMO EU provides QA oversight over all CMO QA activities in the EU. This includes qualification, day to day operational activities, KPI, auditing reporting and exiting/transferring activities. ...

Requirements:

ProClinical is working with a client that has recently acquired a biologics division to add to their vast product portfolio. They are a Global Pharmaceutical company and looking for dedicated support to establish oversight in the EU CMO activities. QA Manager CMO EU provides QA oversight over all CMO QA activities in the EU. This includes qualification, day to day operational activities, KPI, auditing reporting and exiting/transferring activities.

This position is in the Corporate QA Biologics and CM Department and will report into Head Corporate QA Biologics and CM. There is also an expectation of 10% to 15% of travel.

Job Responsibilities:

* Qualify, manage, support and supervise assigned CMO sites aligned with the clients Quality Management Systems. Implement, report and monitor Key Performance Indicators (KPI) and ensure that all are working in a consistent manner
* Responsible for ensuring the Quality Assurance Agreements are created and maintained according to the client’s requirements, regularly reviewed and followed.
* Manage all QAA’s with CMOs and participates in contract negotiations, audits, disputes, and supply agreements.
* Execute, implement and maintains a Quality Risk Management program that assesses the individual Quality Risk Assessments of Drug Product & Medical Device for assigned CMO sites, along with the adequacy of proposed CAPA plans.
* Manage (initiate and investigate) all significant quality issues associated with Drug Products or Medical Devices originating from assigned CMO (complaints, deviations, recalls, counterfeits and product tampering, stability failures, etc.) appropriately and in a timely fashion.
* Provides support for readiness regulatory agency inspections and requests, interacts directly with CMO’s to resolve quality issues.
* Maintain an annual auditing program, participate in technical visits and/or audits, manage action plans and follow up on agreed upon CAPAs.

Skills and Requirements:

* Bachelor’s Degree in (Bio-) Chemistry, Pharmacy, Biotechnology or similar education.
* Minimum of 5 years of experience in manufacturing of (bio) pharmaceuticals drug product / medical devices, bioanalytical background and Quality Assurance. Operational knowledge of aseptic processing and packaging operations is a plus. Experience managing CMO is desired.
* Strong understanding of regulatory requirements for commercial products
* Proven track record with FDA, EMEA and other Health Authorities.
* Strong understanding of risk assessment and risk management fundamentals/tools
* Strong Technical understanding of pharmaceutical processes
* Strong cGMP experience and knowledge, QA/QC and regulatory compliance (US, EU and other international agencies)

To Apply:

Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Badria Kahie on +44 203 8718 094 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Apply for this job: QA Manager CMO EU

Contact Information:

Address:  ProClinical Ltd
Eldon House Eldon Street London
EC2M 7LS
England
Tel:  0800 988 4437
Fax:  +44 (0)207 834 9470
Website:  Visit Our Web Site

Advertising
Site Map | Privacy & Security | Cookies | Terms and Conditions

PharmiWeb.com is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on PharmiWeb.com is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.