Compliance Specialist
- Employer
- Planet Pharma Staffing Limited
- Location
- Dublin (City), Leinster (IE)
- Salary
- Competitive Rate in line with skills and experience
- Start date
- 6 Feb 2021
- Closing date
- 8 Mar 2021
View more
- Discipline
- Quality, QA / QC, Qualified Person, Regulatory Affairs, Compliance
- Hours
- Full Time
- Contract Type
- Contract
- Experience Level
- Experienced (non-manager)
Job Details
Role – Compliance Specialist
Location – Dublin
Rate – Competitive
Type – Contract
Summary:
For one of Planet Pharma’s global Pharma clients, we urgently seek a skilled Compliance Specialist to join on an initial 10-month contract. In this role you will support audit preparation and inspection readiness activities as required, in collaboration with the Compliance & Internal Audit teams. Essentially this role would suit someone coming from a QA or Compliance background.
Responsibilities:
- Lead the preparation activities for the submission of the site Manufacturer’s Importation Authorisation (MIA)/Commercial GMP license application
- Lead the preparation of the Site Master File and associated site documentation required as part of MIA submission
- Support for related Compliance deliverables in support of audits and inspection readiness
- Support for Recall QMS topic
- Provide Quality and cGMP input and support for audit and inspection readiness activities
- Support the site Document / SOP management systems
- Support for various GMP and Quality Training programs & Knowledge Management activities
- Support for MIA variations, as applicable
- Other general specified tasks e.g. global quality metrics, internal audit metrics
- Provide compliance contribution to project teams and leads small projects
Qualifications:
- Minimum 6-7 years pharmaceutical and/or biotech industry experience in Quality/ Compliance related role; experience in a QP role is desirable
- Experience in startup biotechnology facilities a distinct advantage
- Experience of MIA submissions, Site Master File compilation and electronic quality management system tools is required
- Sound awareness and understanding of pharmaceutical business, especially with regards to quality, compliance and regulatory requirements
- Demonstrated problem solving capabilities and technical writing capability
Apply now for immediate consideration or contact Michael Owusu-Ansah on +44 203 928 6631
Company
Planet Pharma was founded by a dedicated team of professionals with extensive experience supporting the pharmaceutical, biotechnology, and device industries.
Our goal is to create an organization that strengthens the employer-employee dynamic by connecting clients with talent. This results in making staffing more personal and creating enduring, valuable relationships. We value communication with our clients and make it our priority to have the hiring process be as fast and successful as possible.
We leverage cutting-edge technology and flexible service delivery models that provide efficient, personalized solutions for your business.
Our global headquarters is in Northbrook, IL and branch offices are based across the United States and Europe.
- Website
- http://www.planet-pharma.co.uk/
- Telephone
- +44 203 868 1000
- Location
-
10 Greycoat Place
London
England
SW1P 1SB
United Kingdom
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