QA Officer Documentation (Part Time)

Ethypharm Group; Tarragona; Presencial; EUR 30.000 - 50.000; A tiempo parcial

Descripción de la vacante

Ethypharm Group is seeking a part-time QA Officer Documentation to ensure compliance and accuracy in quality documentation at their Romford facility. The role entails managing GxP documents, overseeing lifecycle management, and supporting quality assurance processes within a regulated pharmaceutical environment. Ideal candidates should possess strong organizational skills, a background in quality systems, and the ability to work independently while coordinating with various departments.

Servicios

25 days annual leave, rising to 30 with service

Discretionary bonus scheme

Salary Sacrifice scheme for Electric Vehicles

Holiday Buy/Sell scheme

Formación

• Minimum 1-2 years' experience in a Quality Systems / Pharmaceutical environment.
• Prior experience in a QA or Documentation role within a GxP-regulated industry.
• Knowledge of data integrity principles (ALCOA+).

Responsabilidades

• Manage and maintain GxP documents and records in compliance with regulatory requirements.
• Oversee creation, review, issuance of quality-critical documents.
• Provide training on document management processes.

Conocimientos

Data integrity

Organization

Communication

Educación

A Level standard (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: 13.50

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 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 (CoAs).
• 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 in a Quality Systems / Pharmaceutical environment.
• Proven experience of data integrity.
• Familiarity with Microsoft Office software.
• Experience with electronic document management systems (e.g., DocuSign).
• Bachelor's degree in a related discipline.
• Prior experience in a QA or Documentation role within a GxP-regulated industry.
• Knowledge of batch documentation, SOP lifecycle management, and Certificates of Analysis (CoA).
• Knowledge of data integrity principles (ALCOA+).

About You

We are looking for a highly organized, proactive QA Officer Documentation with excellent communication skills. Ability to manage multiple priorities and meet deadlines, working independently and collaboratively, is essential.

Additional Information

This role is on-site at our Romford facility.

What We Offer

• Up to £10,000.00 per annum (PTE).
• 25 days annual leave pro-rated, rising to 30 with service plus bank holidays.
• Holiday Buy/Sell scheme.
• Discretionary bonus scheme (based on policy eligibility).
• Benefits platform with discounts, wellbeing support, and more.
• Salary Sacrifice scheme for Electric Vehicles (dependent on eligibility).

Working Hours

• Monday, Thursday, and 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. Our Romford site is a modern facility dedicated to manufacturing and packaging medicines.

We value diversity and provide equal opportunities, open to flexible working arrangements.