Technical Writer/Compliance Specialist

Technical Writer/Compliance Specialist
QPTech-IT-190321

Recruiters Comments: Our client, a pharmaceutical multinational is currently looking for a Technical Writer/Compliance Specialist to join their team in Limerick. This is initially a 12-month contract with a strong possibility of extension.

Job Description:

 

  • Manage Deviations, CAPA, Change Control, Audits, and Quality risk management.
  • Provides periodic reviews of department documentation and records such as Periodic Evaluation Reports (PER), logbooks, preventative maintenance records/work orders, etc.
  • Maintaining electronic systems used for change control and deviation management.
  • Responsibility for ensuring compliance with all aspects of Quality
  • Responsible for generating and maintaining Life cycle document across automation platforms.
  • Responsible for the approval of deviation notification, driving deviation investigation and tracking implementation through to closure of associated corrective action.
  • Responsible for generating and tracking Quality compliance metrics.
  • Liaise with QA to provide accurate and efficient communication ensuring clarity on all technical investigation and proposed technical solutions.
  • Coordinate Compliance activities with and seek team support from QA, Validation Engineering and Manufacturing.
  • Reviewing and maintain procedures, polices and other instructional documents with a focus on continuous improvement.
  • Ensure consistency by provide guidance and direction in the preparation of all Compliance/Validation documents.
  • Maintains knowledge of current good manufacturing practices (cGMPs).

Role:

Education and Experience:

  • Primary degree in Science/Engineering discipline.
  • You will have a minimum of 5 years’ experience working with validated Automation systems in the pharmaceutical manufacturing environment.
  • Excellent written, presentation, communication and investigation skills.
  • Ability to work on own initiative, without direct supervision from management.
  • Team player with an ability to work well across various departments on site as well as business partners.
  • Direct experience and in-depth knowledge of automation platform desirable.
  • Deadline focused individual.

 

 

Clicking the “Apply Now” button means that you agree to the processing of your personal data for the purposes of current and future recruitment processes, carried out by QPTech in accordance with the provisions of the General Data Protection Regulation (GDPR) (EU) 2016/679.You also agree to share your personal data with other entities of QPTech and potential employers for purposes related to the recruitment process. QPTech may also contact you from time to time to inform you of events we are hosting that you may find interesting.

Providing data is voluntary, you have the right to inspect, correct or request deletion of your data at any time. A request to delete data means withdrawal from any further engagement in QPTech’s recruitment processes and will result in the immediate deletion of your data. If you do not agree, please do not click the “Apply Now” button.

Please visit QPTech’s website to read the full Privacy Policy (https://www.qptech.ie/privacy-statement/)

 

 

 

 

Salary:
Recruitment Contact
Orla Ryan – Recruitment Consultant

Contact: Orla Ryan

Telephone: 061209510

Email: hr@qptech.ie

Apply For This Job

    Upload CV:

    Share This Job
    Be social and spread the word ...