Qualified Person - GSK0JP00093220

Qualified Person - GSK0JP00093220
  • Competitive
    ANNUM
  • Temporary
  • Harlow, Essex, England, UK Harlow Essex UK CM19 5AD
Job Ref: J2163287
Sector: Clinical
Sub-sector: Pharmaceuticals
Date Added: 11 January 2022
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 role:

  • 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).

Requirements:

  • 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.santoro@srgtalent.com

SRGTalent
10/02/2022 15:18:57
GBP 0.00 0.00 Annum
Contact Consultant:
Natalia Santoro

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