Do you have experience working in QA or are you interested in a career as a QA professional?
Do you have experience in the Pharmaceutical/Drug Development industry, working to GLP regulations?
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 organizations.
We strive to make a difference to people’s everyday lives by bringing essential products to the market and as a GLP Quality Assurance Officer at Covance based at Harrogate, you will play an essential part in making this happen.
An individual in this role verifies compliance to applicable Standard Operating Procedures (SOPs) and regulations (GLP and/or GCP) by performing study protocol, data, report, in-lab phase inspections where applicable, for several specific study types.
Responsibilities will include:
- Performs protocol, data, report, and in-lab phase inspections for specific study types to verify conformance to applicable SOP and regulatory requirements
- Evaluating responses to inspection reports and performing follow-up with respondents, management, or others, if needed, to ensure resolution.
- Ensuring that systems used in QA are properly maintained (e.g., QA audit records, training records).
- Performing SOP reviews and acting as initiator for local QA SOPs as appropriate
- Notifying management of service failures.
- Managing all aspects of personal, daily micro-scheduling, organization and prioritization related to a full workload.
- Performing study sign-off including but not limited to QA statement preparation/review (internal/external) and report finalization.
- Participating in internal facility and supplemental inspections.
- Delivering basic quality/regulatory training.
- Actively participating in process improvement and harmonization efforts that promote best practices.
- Performing other related duties as assigned.
Level of education required (or experience level which may be substituted for level of education).
Professional designations/certifications/licenses required
- Bachelor of Science/Arts (BS/BA) degree; degree in a science field is preferred but not essential (e.g. chemistry, biology, animal science)
- Recognised qualifications to support proficiency in basic numeracy and literacy (precise details will be dependent on the country of location).
- Ability to perform basic computer skills (e.g., Word, Excel, PowerPoint)
- In exceptional circumstances, directly relevant previous experience may be substituted for degree requirements.
All candidates would be considered on their own respective merits.
To apply for this job please visit topspotjobs.com.