Quality Associate - Good Manufacturing Practice (GMP)
- Experience Level
- Experienced (non-manager)
Are you interested in starting a career as a trainee Quality Assurance professional?
Do you want to work in the Pharmaceutical/Drug Development industry?
Do you want to work for a company that helps build a healthier and safer world?
As one of the world's premier Contract Research Organisations, we provide research services for a multitude of organisations.
We strive to make a difference to people's everyday lives by bringing essential products to the market and as a Quality Associate at Covance by Labcorp, based at Harrogate, North Yorkshire,you will play an essential part in making this happen.
The Quality Associate is responsible for supporting the local implementation and operation of the GMP Quality Management System. The role aims to ensure the site remains in a state of GMP compliance by participation in investigations, audits, data reviews, validation projects and the delivery of GMP related training, etc. This role is a trainee position; therefore, the following duties will require training/supervision:
Responsibilities will include:
- Performs a preliminary regulatory review to provide recommendations regarding the compliance status of study related documentation (i.e. protocols, reports, certificates of analysis, etc) prior to QA approval
- Reviews and approves site quality documents (Standard Operating Procedures (SOP's), Policies, etc.) to ensure compliance with GMP, Covance document management procedures and other applicable quality standards
- Supports the GMP QA internal audit programme by participating as trainee in audits of GMP-related systems, processes and facilities
- Participates in projects as trainee to ensures facilities, utilities, equipment and computer systems are appropriately validated/qualified
- Review of metrology methods and specifications for accuracy/relevance and compliance with appropriate standards
- Participates as a trainee in investigations (deviations, OOS, customer complaints, etc.) assisting senior GMP QA personnel to assign cause and resolution of quality defects
- Participates as a trainee to continual improvement initiatives aimed at improving the efficiency/ effectiveness of GMP operations
- Delivery of basic GMP training in due course
- A minimum of a Bachelors Degree or equivalent in a Pharmacy, Chemistry or Biology related discipline.
- Good communication, decision making, negotiating, and problem solving skills
- Experience in GMP / GLP or simmilar regulations - likley from a lab environment.
- Customer service orientated, i.e. ability to interact effectively with clients
- Experience in process improvement preferable
- Ability to work under minimal supervision
- Computer literate
- Good verbal and written communication in English