Document Controller

Location: Deeside, Wales, UKDepartment: QualityReference: VN089

Document Controller

Summary of Role

The Document Controller is responsible for maintenance, update and continuous compliant improvement of a cGMP document system that supports the efficient control and management of the organisation’s documents.

Responsibilities
  • To maintain and update a cGMP compliant document and data control system.
  • To manage all aspects of paper & electronic document control within the organisation.
  • To work closely with all functions and departments to ensure efficient running of the system according to cGMP and other regulatory requirements.
  • To manage the process of distribution and communication of documents with both internal and external bodies.
  • To manage and organise the availability of documents during customer & Regulatory inspections.
  • To be an integral part of the Quality Team.
  • Continuous improvement of the management of documentation.
  • Ensure document tracker and metrics systems (e.g. SOPs, CAPA, Deviation, Change Control) are up-to-date and document owners are informed of requirements.

Key Skills and Competencies
Required
  • Ideally, HND/Degree or equivalent qualification in a relevant subject area.
  • At least 1 years’ experience in GMP
  • Experience in a documentation control role (preferably in a GMP environment).
  • Experience in the application of GMP in a manufacturing environment
  • Excellent organisational skills.
  • Experience using Microsoft Office suite of programs.
  • Ability to work accurately, with attention to detail.
  • Ability to prioritise and deal effectively with a varied workload.
  • Good communication skills with the ability to form strong working relationships with stakeholders at all levels across the organisation.
Desirable
  • A good understanding of the application of cGMP to the documentation process
  • An exceptional candidate that has a detailed knowledge of GMP regulatory requirements will be able to apply these to document content.

We also require candidates to be competent with IT systems, and in particular Microsoft Office including Outlook, PowerPoint, Word and Excel.

You will receive

A competitive salary, pension scheme, Perkbox, cycle to work, 25 days annual leave, death in service coverage, on-site health and wellbeing support and medical consultation and physiotherapy, 24/7 employee assistance programme. Training and opportunities for further career development.


Why consider Sterling?

Sterling Pharma Solutions is a global contract development and manufacturing organisation (CDMO) with more than 50 years’ experience in developing and manufacturing Active Pharmaceutical Ingredients (APIs).  This is complimented by Antibody Drug Conjugate (ADC) research and development bioconjugation services.

We are a fast growing, dynamic business with facilities in the UK and the US, where we employ more than 800 talented and passionate people who support our customers in bringing new medicines to market, improving and saving the lives of patients.

Our culture and our way of working is what really sets us apart as a business; we aim to deliver an exceptional experience to our customers and our employees.  You can expect to be part of a supportive team, all working towards a shared goal: to deliver first-class science and service to our customers every day. 

Sterling is an equal opportunity employer. 

Be caring. Be transparent. Be willing. Be reliable.
 
Service. Passion. Science.