QA/ Quality Assurance Lead, Pharmaceuticals

1 week ago

Bolton, United Kingdom Russell Taylor Full time

**QA/ Quality Assurance Lead, Pharmaceuticals**

**Location**: Bolton/ North Manchester area

**Type**: Permanent

**Salary**: £30,000 - £33,000 depending on experience

**Hours**: Days (Monday - Friday),varied pattern depending on business needs; between 9am-7pm

**Additional**:Annual performance bonus, health assured and company ran incentives
- Our Client a Pharmaceutical company (part of a large Pharmaceutical group) is looking to strengthen their QA team. This role has 4 reports / responsible for management of these team members. _
- Support in QMS activities where required.
- Initiate, manage and supervise the process of generation and review of SOPs and other quality related documentation.
- Supervise and maintain temperature and humidity monitoring system and building environmental system.
- Manage the internal audit programme to ensure continued GMDP compliance of site wide activities.
- To ensure internal audit schedule is followed as per procedure and ensure follow up.
- Be responsible for the document control system ensuring issue and archive as per procedure.
- Provide technical expertise to support the customers and answer queries including those related to product investigations.
- Control customer enquiries and product licensing projects.
- Manage and maintain the supplier approval process including the approved supplier list.
- Liaise with suppliers in order to obtain documents needed for Quality Approval.
- Generate supplier audit documentation and technical agreements.
- Support in preparation of external audits and MHRA inspection.
- Ensure timely in-process and stock batch release.
- Govern the system of technical agreements and non-disclosure agreements.
- Supervise Health and Safety tasks within department.
- Liaise with regulatory authorities (MHRA & HPRA) relating to quality and compliance matters.
- Support and manage to resolve customer complaints, recalls, change controls, etc. ensuring proper root cause analysis, prompt responses/resolution.
- Assist in training and education of QA and other teams as advised by the line manager.
- Coordinate and resolve customer complaints ensuring prompt responses, investigation, resolution and feedback.
- Review and approval of new batch manufacturing record and update of record.
- Contribute in document control system including reporting and recording deviations, errors, fails, noncompliance and other quality forms.
- Participate and assist in the process of generation and review of SOPs and other quality related documentation.
- Coordinate the requirements for imported products from EU and non-EU states.
- Participate in training activities and maintain personal training records in an auditable state.
- Utilise scientific sources and interact with all departments in order to work on improving quality of products and services.

**The Person**:

- Good knowledge of GMP related pharmaceutical manufacturing
- 3 years GMP experience in a similar role
- 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

**Salary**: £30,000.00-£33,000.00 per year

**Benefits**:

- Company pension
- Free parking
- On-site parking

Schedule:

- Monday to Friday

Supplemental pay types:

- Bonus scheme

Work Location: In person

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