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Job description

Medreich plc

Location: Feltham, TW13 7HF

Quality Assurance Executive – Full Time

Job Role

The QA Executive is responsible for the Quality Assurance review and approval of all technical documents including but not limited to, testing documents and manufacturing documents.

The QA Executive is responsible for the handling of QMS elements related to the products (complaints, deviations, investigations…) to ensure continuous improvement of the quality of the products manufactured and supplied.

The QA Executive provides assistance to the QP for batch certification and batch release processes.

The QA Executive maintains the data base for new products launch and gathers all required documents and is responsible for suppliers/customers qualifications and bona fide checks.

Job Description

· Listing all tasks and activities undertaken in the employee’s Task List and ensuring the task list is up to date with the progress of these tasks.

· Ensuring that activities (manufacturing, testing, validation) are performed in accordance with GxP, company SOPs and Health and Safety policies.

· Ensuring regulatory compliance with the Company’s product licences.

· Batch release.

· Technical agreements.

· Ensuring appropriate investigation of discrepancies, errors, OOS, or product failures requiring documented review and action.

· Maintaining the on-site data base for products up to date (change controls, complaints, product documentation, stability studies…).

· Handling QMS elements and related trackers.

· Assuring that all QMS element documents are properly completed according to GMP requirements at all stages and approving such documents for implementation and after the completion stage.

· Maintaining electronic records (soft copies) of QMS element documents in the respective folders in the QA Department (draft, approved and closed documents) and filing hard copies in the respective QA folder.

· Tracking the progress of QMS actions (CAPAs, Deviations, CC, Complaints, OOS/LIRs, Investigations etc.) and assuring timely completion and closure, reporting progresses to the line manager as agreed.

· Working with QA colleagues (product experts) to answer quality complaints and medical enquiries.

· Working with QA colleagues and other Departments to complete and close QMS elements.

· Ensuring that all SOPs are current and up to date.

· Working with the rest of the departments on continuous improvements of the QMS.

· Observing and complying with GxPs.

· Observing and complying with company Health and Safety Policies.

· Observing and complying with company Standard Operating Procedures (SOPs).

· Providing support to the rest of the team upon request.

· Undertaking any other duties, either for this department or any other department within the business, which may be requested by the Line Manager, for which training and/or an explanation has been provided and understood.

Key Skills

· Wide knowledge of products and processes used in the manufacture of medicines.

· Wide knowledge in EU GMP requirements

· Good communicator (written and verbal).

· Strong analytical and problem-solving ability.

· Hands-on approach.

· Good organisational skills.

· Ability to prioritise, demonstrating good time management skills.

· Attention to detail, with the ability to work accurately in a busy and demanding environment.

· Committed to learning and development.

· Degree in an associated science subject

· Post qualification experience of working in a similar position.

· Strong team-working skills and communication skills (verbal and written)

The right candidate will also have:

• An enthusiastic, confident, and self-motivated personality and the ability to quickly contribute to the culture and way of working.
• Excellent attention to detail.
• Computer literate and numerate.
• Ability to work in a team environment.
• Ability to work under pressure and meet deadlines.
• Able to work in autonomy and demonstrate engagement and ability to use initiative.
• Able to share experience and good practices with team members.

Salary & Benefits

· Salary £30,000-£35,000 depending on experience.

· Annual bonus (non-contractual, subject to company and individual performance)

· Pension scheme (up to 10% employer contribution)

· Life insurance

· 25 days annual leave

· One day working from home per week on completion of successful probation period.

Job Type: Full-time

Salary: Up to £35,000.00 per year

Benefits:

• Bereavement leave
• Casual dress
• Company pension
• Cycle to work scheme
• Enhanced maternity leave
• Enhanced paternity leave
• Flexitime
• Free parking
• Life insurance
• On-site parking

Schedule:

• Flexitime
• Monday to Friday

Supplemental pay types:

• Yearly bonus

COVID-19 considerations:
Medreich Plc is a COVID secure workplace.

Ability to commute/relocate:

• Feltham TW13: reliably commute or plan to relocate before starting work (required)

Application question(s):

• How many years of Pharmaceutical experience do you have?

Experience:

• QA: 2 years (required)

Language:

• English (required)

Work authorisation:

• United Kingdom (required)

Work Location: In person

Application deadline: 20/10/2023
Reference ID: QA0102