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Job Details

Quality Specialist

Company: Chiltern
Location: Herfordshire
Reference: JT-899160
Closing Date: 15 Dec 16
Type: Contract
Salary (£): On Application
Benefits:

Job Summary:

• Leading Pharma • Hertfordshire • 12 month contract initially • GCP and Pharmacovigilance experience required • Freelance

Requirements:

The Source department of Chiltern acts in a similar way to that of a staffing solutions provider.  My client is a leading Pharma company; they are looking for a Quality Specialist for an initial 12 month contract. The position is full time and would be based at their offices in Welwyn Garden City, Hertfordshire – 2 days per week working from home will be considered after the initial settling in period.

The purpose of the Quality Specialist role is to deliver global procedural document packages for Good Clinical Practice and Good Pharmacovigilance Practice requirements.

The role will include tasks such as:

  • ? Writing global procedures based on interpretation of regulations
  • ? Working with global process owners and other functions to update existing documents
  • ? Quality control output of documents

Primary responsibilities;
• Supports establishment of GxP Standards; Policies & SOP throughout all of the Company development related organizational enterprises (gRED, pRED, PD, GPS and affiliates) to ensure a consistent documents landscape for standards and processes related to clinical development and safety/pharmacovigilance which meet internal and external standards versus regulatory and compliance related regulations and interpretations with Senior Quality Specialist support and coaching
• Builds and maintains strong relationships with key business stakeholders and ensures that PDQ is providing an efficient, effective and compliant process landscape to the functions.
• In close collaboration with supported functional areas and with coaching from senior team members and key business stakeholders, identifies needs for process standardization, regulatory compliance direction and areas for improvement.
• Ensures that business partner expectations for SOP strategy, materials and deployment are met.

A full job description is available.

Candidates are required to have:

  • ? Experience in preparation, development, writing and administration of GxP standards, processes and procedural documents
  • ? Significant experience or knowledge of the pharmaceutical industry, within development and a GxP regulated area.
  • ? Demonstrable knowledge of GCP, Pharmacovigilance/drug safety and regulatory requirements, as well as good analytical, organizational and planning skills.
  • ? Solid knowledge of GCP, PV and regulatory needs.
  • ? Good IT and system skills
  • ? A good working practice that is flexible to work well with global teams but also be very independent

To apply please send a copy of your CV to Julia.thomson@chiltern.com, 01753216725.
Please note, if you skills/experience do not match the requirements for the role you may not get a response.

Apply for this job: Quality Specialist

Contact Information:

Address:  London, UK
171 Bath Road Slough Berkshire
SL1 4AA, UK
England
Tel:  +44 (0) 1753 512000
Fax:  +44 (0) 1753 511116
Website:  Visit Our Web Site

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