SRG are a strategic recruitment partner to a global pharmaceutical company who are looking for a Qualified Person to join the team in Harlow, Essex....
SRG are a strategic recruitment partner to a global pharmaceutical company who are looking for a Qualified Person to join the team in Harlow, Essex.
- The successful person will perform the quality assurance activities and quality oversight of the GMP functions performed within Pharma R&D, Fulfilling the Qualified person responsibilities defined 2001/20/EC and Article 51 of Directive 2001/83/EC. (including Release of Product into the EU which has been manufactured outside EU).
- Key Responsibilities include, but are not limited to:
- Develop and incorporate effective processes and procedures in Product Quality Pharma R&D and may contribute to business processes and procedures outside Product Quality Pharma R&D
- Assure products meet regulatory requirements and that they conform to regulatory submissions.
- May interact with regulators.
- May participate in/manage routine audits/assessments as well as multiple projects of high priority including regulatory inspections and high-risk non-compliance issues.
- Identify business or reputational risks associated with job responsibilities and communicate these upward along with suggestions for risk management solutions.
- Provide advice and consultancy to project teams and external partners to reduce regulatory risks.
- May represent the group as a primary business contact for specific areas.
- Identify and mitigate compliance risks to the company through effective assessments and/or via providing advice and consultancy to Product Quality Pharma R&D and business units regionally and globally.
- Liaise with customers to provide compliance advice/input.
If this role is of interest to you, (or you know anyone who might be suitable), please click the link to apply or email your CV to Natalia Santoro at Natalia.firstname.lastname@example.org
your application has been submitted
Back to job search