QA Manager
- Employer
- Thornshaw Recruitment
- Location
- Dublin (City), Leinster (IE)
- Salary
- Negotiable
- Start date
- 20 Oct 2020
- Closing date
- 19 Nov 2020
Job Details
Quality Assurance Manager – GCP
On behalf of my client, an international biopharmaceutical drug discovery and development company, we are currently recruiting for a QA Manager. Based in Dublin, a prerequisite is GCP experience. This role may be considered as a permanent part time position.
Main Duties / Responsibilities:
- Maintain and develop the Quality Management System (QMS) in accordance with relevant regulatory requirements and business needs
- Implement an effective Quality Assurance process, including internal and external audit programs, and ensure timely completion of audits
- Lead the quality oversight process on outsourced activities, which includes; o Developing and maintaining Technical Agreements with vendors in line with relevant regulatory and business requirements
o Performance of onsite audits as required – vendors / clinical sites
o Analysis and reporting of Key Performance Indicators (KPIs)
- Oversee the effective documentation and tracking of QMS activities, including deviations and change controls, and the implementation of corrective actions.
- Provide quality leadership and support to operational teams, including the review of batch records, technical reports and clinical trial protocols
- Manage the Documentation Control process, ensuring that policies and procedures are up to date, and available to all relevant parties
- Ensure that all activities are conducted in compliance with the requirements of Good Manufacturing Practice and Good Clinical Practice.
- Contribute to Company Training procedures as required
- Carry out various other additional tasks that may be required from time to time in accordance with the overall goals of the company
Requirements:
1) Scientific degree
2) At least 3 years GCP and GMP experience in the pharmaceutical industry
3) QA auditing experience
4) Knowledge of relevant regulatory requirements
5) Excellent interpersonal, communication, and problem solving skills
6) Strong computer skills
7) Flexible in reacting to changing priorities in a dynamic business environment.
8) Ability to travel as required
For a full Job Spec and to apply for this role please call Tina on +353 1 2784671 or e-mail tdunne@thornshaw.com
Thornshaw Scientific Recruitment is a leading Irish provider of specialist Scientific Recruitment. Part of the CPL Group. www.thornshaw.com Tel: +353 1 2784671
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Company
Thornshaw Scientific Recruitment was first established in 1999 and since then has become a leader in Scientific recruitment. In 2005 we partnered with Cpl Resources, one of Europe’s most successful recruitment companies.
Our wealth of experience in specialised recruitment allows us to offer the right solution to each employer, whatever their recruitment requirements.
Over the years we have developed strong relationships with our clients in the market and we pride ourselves on our repeat business from clients.
Our Industries
We are a global provider and have been providing a reputable recruitment service to the Biotech, Pharmaceutical, Clinical Research, Medical Device, Engineering and Healthcare industries for over 20 years.
Our Specialities
Clinical Research, Regulatory Affairs, Quality Assurance, Medical Affairs, Pharmacovigilance, Biostatistics, QC, Validation.
Our Mission
For further details on our services contact Tina at +353 1 2784701 or email tdunne@thornshaw.com
- Website
- http://www.thornshaw.com/
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