Batch Record Generator

5 months ago

Bolton, United Kingdom EASTSTONE SPCIALS Full time

**Job Title**:Batch Record Generator

Reports to: QA Ops Lead / Quality Assurance Manager

Department: Quality Assurance

Responsible for: N/A

Hours per week and details of shift 37.5 hours per week requirements if appropriate: 9am to 6pm, Mon to Fri

Holiday entitlement: 21 + 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 with the Quality Department, accurately verifying and generating batch documentation and labels for manufactured batches and ensuring GMP and GDocP compliance at Eaststone Limited.

Daily Activities
- Generation or review of SOPs and other documents (where applicable)
- Providing support the customers and answering queries and product investigations
- Participate in the internal audit programme to ensure continued GMP compliance of all site activities
- Utilise resources in order to work on improving quality of products, processes 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
- Involved in investigation the following, when applicable, where related to your role:Risk Assessments -Change Controls -CAPAs -Deviations -Complaints Recalls -OOS/OOT
- Trained to manage and destroy products when needed
- To verify batch calculation
- Generate batch documentation
- To complete a start and end of day checklist on a daily basis for batches generated
- Update staff performance matrix using department event logs
- Generate logbooks as and when required
- Manage labelling and printing needs
- Manage daily batch records sheet and submit to line manager on timely manner
- Submit inappropriate batch records for cancellation as and when required
- Bring materials for the Production team on a daily basis and support procurement for the ordering of these materials
- Updating QC logbooks relating to test samples
- Able to manage day to day orders
- Create, Issue, archive and appropriately dispose labels accordingly
- Communicate cut off with Customer Service team
- Update Production, warehouse and material stock take/control logs when required
- 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**: £20,000.00-£25,000.00 per year

**Benefits**:

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

Schedule:

- Day shift
- Monday to Friday
- Overtime

Supplemental pay types:

- Performance bonus

Ability to commute/relo

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