QA Operations Officer

3 months ago

Bolton, United Kingdom EASTSTONE SPCIALS Full time

**JOB DESCRIPTION**

**Job Title**:QA Operations Officer

**Reports to**: QA Ops Lead / Quality Assurance Manager

**Department**: Quality Assurance

**Hours per week and details of shift** 37.5 hours per week

**Holiday entitlement**: 20 + Bank Holidays

**Company Details**

Walkboost Group was established in 2003 and consists of 3 Pharmaceutical companies; all of the companies are based in Bolton. In total Walkboost Group has c110 staff.
Maxearn Ltd is a parallel import company; Quadrant Limited is a licensing company and
Eaststone Ltd is a Specials (unlicensed medicines) manufacturing company.

To oversee the quality of all products manufactured or sourced by the company and ensuring GMP and GDP compliance at Eaststone Limited. To manage the Quality
Management System in the implementation of GMP/GDP documentation across the whole company.

The role will be primarily to maintain Quality Compliance in relation to operational QA and
Cannabis Based Products for Medicinal use. To provide support to the wider Quality
Department and Eaststone as a whole if and when required

**Daily Activities**
- Batch release of manufactured Specials products and Release of Third Party Specials or Special Obtained Products
- Generation or review of SOPs and other documents (where applicable)
- Providing support the customers and answering queries and product investigations
- Coordinate with the QMS team and resolve immediate/urgent customer complaints, ensuring prompt responses/ resolution
- Participate in the internal audit programme to ensure continued GMP compliance of all site activities
- Utilise scientific resources in order to work on improving quality of products and services
- To maintain personal training folder in an auditable state
- To undertake any task required by your Line manager, and for which you have received full training and or an explanation has been provided and understood
- Generate new BMRs and offer technical assistance in product manufacturing as and when required (when covering staff shortages)
- Respond to external and internal medicines information requests
- Maintaining quality documentation system in relation to role activities
- Participate in quality improvement initiatives
- Supporting in the process of archiving documentation
- Supporting and executing external audits where applicable
- Supporting management when hosting regulatory audits
- Involved in investigation the following, when applicable, where related to your role: o Risk Assessments o Change Controls o CAPAs o Deviations o Complaints o Recalls o OOS/OOT
- Trained in importation and exportation of controlled drugs (i.e CBPMs)
- Trained to manage and destroy products when needed
- Supporting the management and control of Supplier and Customer approvals
- Maintaining and monitoring the site temperature monitoring system of equipment and areas
- Performing annual Control Drug returns
- Supporting and executing environmental monitoring
- Supporting in management of Couriers used by Eaststone
- Supporting in generation and management of Technical Quality Agreements
- Creating protocols and reports for any applicable validation activities
- Supporting in Temperature Mapping activities on site
- The list above is not exhaustive

**Key Outcomes**
- Good knowledge of GMP related pharmaceutical manufacturing
- 2 years GMP experience in a similar facility
- Demonstrated compliance with procedures and policies
- Excellent team, interpersonal skills, and communication skills (both written and verbal)
- Ability to interact successfully with multicultural members of staff
- Willingness to work flexible hours
- Safe adoption of working practises together with an understanding of the needs for precise and accurate documentation

**Role Specific Competency Requirements**
- Excellent organisation and communication skills
- Strict attention to detail
- Ability to work as part of a team or using own initiative to ensure efficient work flow.
- Good team player with sound interpersonal skills.
- Motivation, accuracy, discretion and helpfulness are critical to this position
- Excellent problem solving, risk analysis and negotiation skills
- 2 years GMP experience in a similar facility
- Good IT skills i.e. Word, Excel
- Ability to assume responsibility and act on own initiative
- Hands-on approach with a can-do attitude
- Ability to adhere to strict deadlines

**Qualifications**:

- Educated to a Level 2 Qualification

**Shared Company Competency Requirements**
- Customer Focus
- Developing Self/Others
- Team-Working
- Drive & Resilience
- Personal Integrity

Changes with Role (scored between 1 & 5 depending on role/experience)
- Analysing & Decision Making
- Managing Change
- Managing Performance
- Communicating with Impact

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

**Salary**: From £24,500.00 per year

**Benefits**:

- Company events
- Free parking
- Health & wellbeing programme
- On-site parking
- Referral programme

Schedule:

- Monday to Friday
- Overt

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