GMP / GLP Study Director

Job Title: GMP / GLP Study Director
Contract Type: Permanent
Location: Guildford, Surrey
Salary: £26000 - £42000 per annum + company benefits
Start Date: Feb / Mar 2017
Reference: 68440-PHARM-JHY
Contact Name: James Harvey
Contact Email:
Job Published: February 10, 2017 15:28

Job Description

Job title: GMP / GLP Study Director
Job type: Permanent
Location: Guildford, Surrey
Salary: £26,000 - £42,000 / year + company benefits


- My client is a leading pharmaceutical development company with an enviable
product portfolio. I am currently seeking a GLP Study Director to join them on a
permanent basis to project manage scientific research studies

Job purpose:

- To project manage scientific research studies in line with GXP and GMP

Key responsibilities:

- Perform research and development in line with study plans, testing protocol,
timelines, GxP or GMP regulations
- Provide support to study / project transition from first principles of
pharmaceutical development to GMP supplies in line with GxP regulations
- Adhere to company Standard Operating Procedure (SOPs)
- Contribute to the preparation and review of SOPs and Forms where applicable
- Maintain projects in company's internal project management software
- Contribute to the writing of study plans / testing protocols and corresponding
reports and updates for Sponsors
- Management and contribution to client minutes associated with project TC's
- To assist in the smooth running of laboratory activities in line with GxP
- Assist in the smooth running of activities in line with GMP regulations where
- Maintain client relationships and to identify opportunities for additional work
or alternative projects with clients
- Report any amendments and deviations from SOPs and study plans/ testing
protocols to the Study Director/Principal Analyst as appropriate
- Adhere to company Health & Safety Policy and COSHH regulations at all times
and to ensure the safety of others in any procedures or tasks performed
- Collaborate with suppliers upon instruction from the Laboratory Manager and /or
Senior Study Director
- Review literature in preparation for studies and to regularly update knowledge
by reviewing appropriate literature
- Present approved work to stakeholders, conferences and to clients
- Ensure that all documentation, computer data and records are stored
- Assist Data Processors to ensure the correct spreadsheets and data analysis is
- Review project workbooks and data as per SOPs
- Perform appropriate tasks in line with your job at the request of Senior