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Quality Document Administrator

Location Dundalk, Louth
Sector
Job Type Temporary
Salary Negotiable
Published 6 months ago
Start Date ASAP
Contact Melissa Elliott
Job Ref ALM1219_1549976313

Job Description

The Company

They are an award winning, drug development solutions provider at the forefront of the pharmaceutical industry. They are a privately owned organisation that has organically grown over 50 years now, employing almost 5,000 highly skilled staff worldwide. Their Global Headquarters is located in a state of the art facility in Craigavon, Co. Armagh with additional operations throughout Europe (UK, Ireland), across the US and Asia.

Their drive and passion for the values championed by their founder and enshrined in the ethos of the company, ensure that 'Partnering to Advance Human Health' is more than just a strapline - it is their way of life.

Advancing human health requires exceptional people - your talent, experience and passion will be the perfect match. Together you and our client can make an exceptional difference to the health of countless patients all over the world…

OVERALL ROLE OBJECTIVE:

To work as part of a Quality Document Administration team responsible for compilation, issuance and review of GMP documentation. The post holder will assist in the maintenance of the Almac Pharma Services Quality system and will participate in investigations and trending of quality performance indicators as appropriate.

JOB SPECIFIC RESPONSIBILITIES:

The post holder will:

  1. Generate GMP documentation (Master Manufacturing and Packaging Specifications, SOP's, specifications, validation documentation etc) in the approved formats.
  2. Issue batch records in accordance with the Production schedule as outlined in Almac Pharma Services internal procedures.
  3. Issue and retrieve GMP documentation to / from departments as assigned
  4. Circulate quality system related documentation (change requests, deviations, CAPA, suspect analytical results, complaints etc) to all relevant departments
  5. Manage and distribute controlled documents, maintaining current effective versions in hard copy and electronically
  6. Ensure that all designated Document Control storage/ archive areas are tidy, presentable and organised in a logical way
  7. Archive, retrieve and track GMP associated documentation
  8. Collate and review data for QA reports and investigations
  9. Maintain all quality system indexes and electronic tracking systems e.g. WOLF

GENERAL RESPONSIBILITES

  • Ensure GMP is adhered to in all areas of work
  • Understand Company's Health & Safety Policy and follow all company HSE procedures. Report all accidents or any unsafe conditions in the work place
  • Ensure training has been received before undertaking specific duties and that all training is recorded in training records
  • Adhere to all HR policies and procedures, to include all absence policies and procedures
  • Communicate within your own department to ensure that all relevant information is forwarded to the appropriate personnel on a regular and timely basis. Provide regular updates to your line manager regarding progress on required duties and the status of any projects
  • Observe and adhere to the company's Equal Opportunities and Dignity at Work policies ensuring that a neutral and harmonious work environment is maintained in which bullying and/or harassment does not occur
  • Ensure that all job specific responsibilities relating to the overall role objective are carried out in accordance with the requirements outlined within the Almac core competency framework

THE PERSON

  • Please make sure that your CV clearly demonstrates that you meet all of the following essential criteria:
  • Junior Certificate (or equivalent) at Grade C or above in English Language and Maths

  • Previous experience within a Quality System or Manufacturing environment
  • Proven ability to work effectively on own initiative as well as effectively contributing to the team environment

  • Effective communication skills, both verbal and written
  • Proficiency in use of IT applications (Word, Excel, Outlook etc)
  • Excellent attention to detail and Proven ability to plan and prioritise workload

DESIRED

  • Certificate in Word Processing e.g CLAIT, ECDL
  • Previous experience within a Pharmaceutical environment

Contact Details & Deadline

Applicants meeting the criteria will be required to attend a registration appointment with Diamond Recruitment at Almac Craigavon.

To be considered for the position of Distribution Co-ordinator, please forward your CV to Melissa Elliott at Diamond Recruitment Group by clicking on the APPLY button on this page and attaching your CV. This position is closing urgently.

For further information on this opportunity please contact Melissa at Diamond Recruitment Group on 07435751852 however you must send your CV first to allow us to assess your suitability. Your details will be treated in a confidential manner with Diamond Recruitment Group. Only applicants meeting the criteria will be contacted.

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