Quality Documentation Controller

2 weeks ago

Tredegar, Blaenau Gwent, United Kingdom PCI Pharma Services Full time
Life changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.

We are PCI.

Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.

The role


The main purpose of this role is to control and issue relevant GxP documentation which ensures the timely release of product, as well as contribute to ensure that all KPIs, targets and any other deadlines relevant to the role are met.


The nature of the role of Quality Document Controller requires consistency of attitude and behaviour from the job holder to all aspects of Pharmaceutical Quality Assurance and the constant pursuit of excellence and efficiency throughout the organisation.

The role demands high standards of attention to detail and the desire to see tasks through to completion.

A strong problem-solving ability is needed to assist team members in identifying and eliminating problems. Where qualified, the job holder will also be required to train other personnel in quality system procedures and approaches.

Main responsibilities:

  • Maintain electronic documentation system.
  • Maintain document control & document management procedures.
  • Support appropriate investigations of deviations, failures and adverse events in area, requiring documented review and action.
  • Preparation and review of quality / production documentation.
  • Issuing, Archiving and retrieval of Quality Documentation, both onsite and with Service Providers.
  • Provide the highest standards of customer service and support to both internal and external Customers.
  • Ensure services are provided in a timely manner and in adherence to individual and team Deadlines and/or KPIs.
  • Review and improve departmental processes and eliminate waste.
  • Experience of working in an office environment or documentation centre is essential.

Qualifications:

  • Previous experience of working within an Electronic Quality Management System or Electronic Document Control system would be an advantage.
  • Strong administrative and organisational skills.
  • Experience in a similar role in a regulated environment would be beneficial.
  • Excellent organisational skills must be able to effectively manage multiple tasks simultaneously.
  • Good interpersonal skills being able to communicate effectively with a wide range of individuals and groups.
Join us and be part of building the bridge between life changing therapies and patients.

Let's talk future

Equal Employment Opportunity (EEO) Statement:

  • PCI Pharma Services is an Equal _Opportunity/Affirmative_ Action Employer. We do not unlawfully discriminate on the basis of race, color, religion, age, sex, creed, national origin, ancestry, citizenship status, marital or domestic or civil union status, familial status, affectional or sexual orientation, gender identity or expression, genetics, disability, military eligibility or veteran status, or any other protected status._

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