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QA Officer Documentation (Part Time)

QA Officer Documentation (Part Time)

Ethypharm Groupvalència, España
Hace más de 30 días
Descripción del trabajo

Full details of the job.

Vacancy Name

Vacancy Name QA Officer Documentation (Part Time)

Contract

Contract Permanent

Location

Location Romford, Spilsby Road

Salary Up to £29,000.00 FTE

Daily Work Times

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

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 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.
  • 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 of 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+)

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.
  • Essential

  • 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 of Microsoft Office software.
  • Experience with electronic document management systems and tools (e.g., DocuSign).
  • Desirable

  • 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 possess excellent communication skills. Your ability to manage multiple priorities and meet deadlines, while working both independently and collaboratively within a team, will be critical to your success in this role.

    This role is on site and will be based at our Romford site.

    What we offer you

  • 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 – an opportunity to buy or sell up to an additional 5 days of holiday
  • 3% Bonus - In addition to our competitive salaries, all our employees are entitled to join a discretionary bonus scheme (based on policy eligibility)
  • Bravo Benefits Platform – offering a variety of discounts, financial support, My MindPal, wellbeing app, menopause support and more
  • Salary Sacrifice scheme for Electric vehicles with Tusker (dependent on meeting policy eligibility)
  • Medicash Health cash plan
  • Working hours information

  • Monday 10 : 00Am-15 Pm, Thursday 10 : 00 Am-15Pm and Friday 10Am-15 Pm
  • Please note, at present, we are unable to assist with sponsorship for right to work.

    Why Ethypharm?

    Ethypharm is a leading mid-sized international pharmaceutical company, with strong European roots, that manufactures and provides essential medicines, with a focus on hospital care, central nervous system (severe pain and addiction) and internal medicine.

    Ethypharm has 1,700 employees dedicated to its various pharmaceutical activities, of which 1400 are in industrial operations. Our six production sites located in France, the UK, Spain,

    and China have expertise in injectables and complex oral solid forms.

    At Ethypharm, you will be a part of a team dedicated and committed to improving patients’ lives.

    Our Romford facility is located 20 miles from the centre of London and consists of over 6700 square metres of a high-quality, modern pharmaceutical facility where we mix, fill, sterilise, inspect, pack, and label a wide range of medicines.

    At Ethypharm we recognise the value of diversity in the workplace and provide equal opportunities for all. We are always open to discussing flexible working arrangements where this meets with the needs of our business.

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