Quality Assurance Officer

3 weeks ago


Derby, United Kingdom Tentamus UK Full time

**Quality Assurance Officer**

Tentamus UK are currently seeking a Quality Assurance Officer to work in our QA department at our GMP pharmaceutical site in Derby.

**Description**
Reporting to the QA Manager this position is responsible for undertaking general QA activities in support of the Operations department. As a service provider you will be a key position ensuring we deliver excellence in quality and turnaround to our customers. Our laboratory operates according to EU cGMP, experience of working in a GMP environment is an advantage but is not essential.

**Your Primary Responsibilities**
- Comply with company SOPs
- Provide input and assessment to equipment qualification
- Support batch release activities
- Prepare customer test/technical protocols and reports
- Record all activities on relevant databases
- Effectively manage quality assurance activities including change controls, non-conformances, corrective and preventive actions, OOS, training, risk assessment, document distribution and trending when required
- Periodic review of test methods and specifications
- Revise the specification documents
- Manage the customer complaints
- Produce weekly / monthly activity and performance reports for Management
- Maintenance of Pharmaceutical Quality System documentation
- Ensure that the core current Good Manufacturing Practice (cGMP), Good Control Laboratory Practice (GCLP), and Data Integrity are maintained
- Initiate, write and review SOPs as required
- Coordinate internal audits
- Co-ordinate SOP / documentation management system (G-docs) and provide technical support and training to Tentamus Pharma UK staff.

**To succeed in this role, you will have the following capabilities**:

- First degree in scientific discipline
- 1- 3 years’ experience in responsible and equivalent position within GMP environment.
- Fully competent in oral and written communications with strong interpersonal and management skills.
- Ability to work well and collaborate within a team environment
- Excellent communication skills in providing feedback and pinpointing improvements where needed
- Have keen attention to detail to ensure all products and services meet standard requirements

**Your Basic Qualifications**
- Highly computer literate, e.g. Microsoft Office

**Job Types**: Full-time, Permanent

**Salary**: £22,500.00-£25,000.00 per year

**Benefits**:

- Casual dress
- On-site parking

Schedule:

- Holidays
- Monday to Friday

Work Location: One location

Reference ID: QAOFFICER



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