Quality Assurance Officer
- Recruiter
- Covance
- Location
- Harrogate
- Salary
- Market related
- Posted
- 13 Aug 2014
- Closes
- 10 Sep 2014
- Ref
- CCC/KH143-QAO
- Contact
- Covance .
- Sectors
- Scientific & Pharmaceutical
- Contract Type
- Permanent
- Hours
- Full Time
At our Early Development site in Harrogate we are recruiting for a Quality Assurance Officer (Level 2) to support compliance with Good Manufacturing Practice (GMP).
The GMP Quality Assurance Officer is responsible for reviewing and approving departmental procedures and for participating in a programme of audits and self inspections to ensure the site remains in compliance with GMP and Covance Policies and Procedures.
The role is a development role leading up to GMP Quality Assurance Officer level 3
Job duties are as follows:
- Monitors the effectiveness of the GMP Quality Management System and provide trend data for input into the Management Review Process
- Reviews and approves departmental quality documents (SOPs, Policies, etc) to ensure compliance with GMP, Covance document management procedures and other applicable quality standards
- Performs regulatory review of study related documentation (i.e. batch records, protocols, reports, certificates of analysis, etc) prior to approval by senior GMP QA personnel
- Supports the GMP QA internal audit programme by participating in audits of GMP-related systems, processes and facilities
- Participates in projects providing recommendations 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 quality standards
- Participates in investigations (deviations, OOS, customer complaints, etc) to help assign cause and resolution of quality defects
- Contributes to continual improvement initiatives aimed at improving the efficiency/ effectiveness of GMP operation
The successful candidate:
- A minimum of 5 years operating in a GMP environment; at least 1 years experience in GMP QA
- In depth knowledge of Good Manufacturing Practice Regulations
- General awareness of industry quality systems/standards, e.g. ICHQ10, ISO 9000
- Good communication, decision making, negotiating, and problem solving skills
- Experienced GMP Auditor
- Experience in process improvement preferable
- Ability to work under minimal supervision
- Computer literate
Quality Assurance Officer - Education/Qualifications
- Degree (or equivalent) in Pharmacy, Chemistry, Biology related discipline relevant postgraduate degree (e.g. MSc)
Quality Assurance Officer - The successful candidate will have:
- A minimum of 5 years operating in a GMP environment; at least 1 years experience in GMP QA
- In depth knowledge of Good Manufacturing Practice Regulations
- General awareness of industry quality systems/standards, e.g. ICHQ10, ISO 9000
- Good communication, decision making, negotiating, and problem solving skills
- Experienced GMP Auditor
- Experience in process improvement preferable
- Ability to work under minimal supervision
To submit your CV for this exciting Quality Assurance Officer opportunity, please click 'Apply' to be redirected to the Covance careers page.