Senior QA Officer

**NextPharma is a leading European pharmaceutical CDMO focused on attractive technology niches.**

**Our Vision**:
Our vision is to be the leading and most trusted, reliable and innovative Europe-based CDMO by upholding the highest industry standards and exceeding customer expectations, while driving strong, sustainable growth for the company.

**Job Purpose**

Reporting to a QA Manager this role is responsible for providing systemic support to the QA Department.

The ability to manage others would be beneficial.

**Key responsibilities and accountabilities**:
1. Support to the site QMS including routine review and approval of change controls, deviations, action plans and audit CAPA and trending of QMS data

2. Review and approval of SOPs

3. Review, approval and issue of manufacturing, analytical and validation documentation

4. Participation in root cause analysis investigations arising from deviations

5. Lead and/or support both internal and external audits including writing reports, agreeing follow up actions and tracking these to closure

6. Participation in desk-based audits in support of the supplier assessment program as required

7. Review and approval of risk assessments and validation documentation as required

8. Perform annual Product Quality Reviews as required

9. Provide input to and support continuous improvement initiatives

**Person Profile: Senior QA Officer**

1. Results oriented with a positive outlook and clear focus on high quality output

2. Able to demonstrate strong organisation and negotiation skills

3. Able to demonstrate good written and verbal communication skills

4. Able to get on with others and be a team player, but be equally comfortable working independently

5. Able to demonstrate good attention to detail

6. Able to work in a fast, stimulating environment

7. Reliable, tolerant and dependable

8. Comfortable dealing with senior managers, customers, external auditors and suppliers

9. Willing to learn from others

**Personal Situation**

Flexible and able to work extended hours when required.

**Specific Job Skills**:
Required:

- Experience of working in a similar Quality role within a GMP environment, idealy within a manufacturing facility
- Experience of document review and approval
- Audit experience (internal and supplier auditing)
- Able to communicate effectively with people at all levels in a Company.
- Able to write clear, concise reports

Desired:

- Audit experience, MHRA and/or FDA
- A degree or equivalent in Chemistry, Pharmacy, Biology or general science.
- A knowledge of MasterControl® or similar quality management system
- A knowledge of SAP® or other ERP system

**Computer skills**:
Must be competent in the use of MS Office, particularly Excel and Word, Outlook and navigation of the internet via web browsers. Must demonstrate an aptitude to acquire new software skills as required

**Literacy and Numeracy**:
Must be competent in writing scientific reports both for internal use and for customers/clients.

Must be numerate and able to trend and interpret data.

**Business Presentation Skills**:
Must be able to give clear and concise oral presentations

**Remuneration Package**:
Basic Salary: £DOE

Private Medical Insurance

Health Cash Plan

Contributory pension scheme

Life Insurance

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

**Benefits**:

- Company events
- Company pension
- Life insurance
- On-site parking
- Private medical insurance
- Referral programme
- Sick pay
- Wellness programmes

Schedule:

- 8 hour shift
- Monday to Friday

Ability to commute/relocate:

- Livingston, EH53 0TH: reliably commute or plan to relocate before starting work (required)

**Education**:

- Bachelor's (required)

Work authorisation:

- United Kingdom (required)