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QA Officer Documentation (Part Time)

Ethypharm Group

Oviedo

Presencial

GBP 29.000 - 35.000

A tiempo parcial

Hace 3 días
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Descripción de la vacante

A leading international pharmaceutical company is looking for a proactive QA Officer Documentation on a part-time basis. The successful candidate will support the management of quality documentation ensuring compliance with regulatory requirements and company policies. This role requires excellent organizational skills, and offers up to £29,000 (FTE) per year along with additional benefits.

Servicios

25 days annual leave pro-rated
Holiday Buy/Sell option
3% Bonus discretionary scheme
Bravo Benefits Platform
Salary Sacrifice scheme for Electric vehicles

Formación

  • Minimum 1-2 years' experience in Quality Systems/Pharmaceutical environment.
  • Familiarity with batch documentation and SOP lifecycle management.
  • Knowledge of data integrity principles (ALCOA+).

Responsabilidades

  • Oversee the creation, review, issuance, and lifecycle management of quality-critical documents.
  • Maintain compliance of documentation processes with internal and regulatory requirements.
  • Provide training and guidance on document management processes.

Conocimientos

Data Integrity
Documentation Management
Communication
Proactive

Educación

A Level or equivalent
Bachelor's degree in a related discipline

Herramientas

Microsoft Office
DocuSign

Descripción del empleo

Vacancy Name : QA Officer Documentation (Part Time)

Contract : Permanent

Location : Romford, Spilsby Road

Salary : Up to £29,000.00 FTE

Daily Work Times : Monday 10 : 00 - 15 : 00, Thursday 10 : 00 - 15 : 00, Friday 10 : 00 - 15 : 00

30 min break each day. Start time can be negotiated.

Basic Hours Per Week : 13.5

Job Description

We are recruiting a QA Officer Documentation (Part Time)

Ethypharm is seeking a proactive and experienced QA Officer – Documentation to ensure the accuracy, control, and compliance of quality documentation in alignment with business and regulatory requirements.

Purpose of the role :

To manage and maintain GxP documents and records in compliance with current Good Manufacturing Practices (cGMP), regulatory requirements, and company policies. Ensures that documentation supports operational needs while maintaining integrity and compliance throughout the document lifecycle.

Day-to-day responsibilities :

  • Oversee the creation, review, issuance, and lifecycle management of quality-critical documents (e.g., SOPs, Work Instructions, specifications, logbooks).
  • Maintain compliance of documentation processes with internal procedures and external regulatory requirements.
  • Manage document archiving in line with company record retention schedules.
  • Generate and manage manual Certificates of Analysis (CofAs).
  • Issue and verify batch documentation for accuracy and compliance.
  • Maintain and update departmental documentation reports and KPIs.
  • Support PQS elements including Change Control and CAPA processes.
  • Serve as the system expert for DocuSign, ensuring effective configuration, user support, and compliance with data integrity standards.
  • Assist with troubleshooting and continuous improvement of the electronic signature and document approval process.
  • Provide training and guidance to departments on document management processes and system use.
  • Contribute to the development and delivery of training materials related to documentation practices and systems.

Qualifications and Experience :

  • Educated to A Level standard (or equivalent)
  • Minimum 1-2 years' experience working in a Quality Systems / Pharmaceutical environment
  • Proven experience of data integrity
  • Familiarity with Microsoft Office software
  • Experience with electronic document management systems and tools (e.g., DocuSign)
  • Bachelor's degree in a related discipline
  • Prior experience in a Quality Assurance or Documentation role within a GxP-regulated industry (e.g., pharmaceuticals, medical devices, biotech)
  • Familiarity with batch documentation, SOP lifecycle management, and Certificates of Analysis (CoA)
  • Knowledge of data integrity principles (ALCOA+)

About You

We are looking for a dedicated QA Officer Documentation who is highly organised, proactive, and possesses excellent communication skills. Your ability to manage multiple priorities and meet deadlines, while working both independently and collaboratively, will be critical to your success in this role.

Additional Information

This role is on-site at our Romford site.

What We Offer

  • Up to £10,000.00 per annum (PTE)
  • 25 days annual leave pro-rated, rising to 30 with length of service plus bank holidays (prorated)
  • Holiday Buy / Sell – buy or sell up to 5 additional days of holiday
  • 3% Bonus – discretionary scheme based on policy eligibility
  • Bravo Benefits Platform – discounts, financial support, wellbeing app, menopause support, and more
  • Salary Sacrifice scheme for Electric vehicles with Tusker (dependent on policy eligibility)

Working Hours

  • Monday, Thursday, Friday 10 : 00 - 15 : 00

Please note, we are currently unable to assist with sponsorship for right to work.

About Ethypharm

Ethypharm is a leading international pharmaceutical company with a focus on hospital care, CNS, and internal medicine, with manufacturing sites across Europe and China. Our Romford facility is a modern pharmaceutical site dedicated to high-quality production.

We value diversity and are committed to equal opportunities and flexible working arrangements.

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