QA Executive

4 months ago

Bolton, United Kingdom Crescent Pharma Full time

Job description

**JOB PURPOSE**:
To support the other QA Executives, Quality Manager and QPs in the generation and revision of Quality documentation, as well as the review and compilation of batch-related documentation, generated both internally and externally.

**PRINCIPAL ACCOUNTABILITIES**:

- Review of the batch manufacturing/testing/packaging documentation for compliance with approved procedures and the product licence, for submission to the Qualified Person for release.
- Liaising with contract laboratories to ensure the timely analysis of products in preparation for EU QP certification.
- Management of the archiving of Quality Management documentation, product samples and batch release paperwork to ensure compliance with company policies and procedures as well as regulatory guidelines.
- Liaising with suppliers regarding quality or batch related issues, assisting with investigations, where necessary, and supporting the resolution of issues.
- Ensuring that all changes are entered into appropriate quality systems to ensure the change is consistently implemented to the required standards, with all relevant and supporting activities undertaken.
- Providing support for the initiation of any regulatory changes by providing relevant and appropriate data packages and reports.
- Writing and review of Deviation Reports and CAPAs associated with Crescent Pharma products or contact activities carried out using Crescent Pharma product licences.
- Review of master processing documents against licence details and Technical Agreements prior to use.
- Participation in the internal audit programme.
- Participation in external audits of Crescent suppliers (as appropriate) and providing support for any assessment activities.
- Participation in regulatory audits at Crescent (as appropriate) and providing support for assessment activities.
- Providing support in maintaining the Crescent Documentation System to ensure that all critical procedures are documented and are in compliance with company policy and regulatory requirements.
- Requesting, executing and reviewing Product Quality Review reports.
- The writing and amendment of Standard Operating Procedures that cover GxP activities.
- The review and processing of, and responses to customer complaints.
- The creation, review and approval of process/analytical/equipment/system validation protocols and reports.
- Providing support in project based activities.
- Providing training as requested, and in line with current internal policies regarding training, to support ongoing GxP requirements and understanding.

**PLANNING, ORGANISING AND CONTROLLING**:
Planning and organising own allocated workload to ensure that projects are completed within the timeframe agreed with management and, to ensure that individual and departmental objectives are met


**CONTACT WITH OTHERS**:
**Internal**

QA

Regulatory

Supply Chain / Planning

Customer Services

Warehouse

Sales & Marketing

**External**

Third Party Sub-contractors (EU and Non-EU)

Regulatory / QP Consultants

Customers

**MAJOR CHALLENGE OF THE JOB**:
To assist in the maintenance of existing quality standards in line with company policies and regulatory guidelines, to ensure the quality of Crescent Pharma’s products and sub-contractors.

**KNOWLEDGE, SKILLS AND EXPERIENCE REQUIRED**:

- Educated to degree Level standard, or equivalent. A degree in Chemistry, Pharmacy, Biochemistry, Microbiology or Biology would be desirable.
- Effective time management skills with a flexible approach and the ability to adapt quickly to changing priorities.
- Self-motivated and organised with ability to work using own initiative and as a team.
- Good attention to detail and ability to follow defined procedures and regulatory guidelines.
- Excellent interpersonal and communication skills.
- Good IT skills (Excel, PowerPoint, Outlook, Word).

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

**Salary**: £25,000.00-£30,000.00 per year

**Benefits**:

- On-site parking

Schedule:

- 8 hour shift

**Experience**:

- Quality Assurance: 5 years (preferred)

Work Location: In person

Reference ID: CRESMEDEX

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