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Quality Operations Manager/QP, Westmeath



Westmeath, Ireland 

Job Category:

Biotech/Pharma, Science

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Job Description:

Team Horizon currently has an exciting opening for a Quality Operations Supervisor to work on our client’s manufacturing facility in the midlands. The role has responsibilities in relation to Group Quality Management System and CMO Compliance on a dotted line reporting basis to Director of Quality and Regulatory

Why you should apply:

  • The company manufacturers and distributors for speciality off-patent/generic pharmaceuticals across the UK, Ireland and international markets
  • Our client’s portfolio of products is diversified across multiple therapeutic areas, with particular strengths in analgesics and anti-infectives.
  • Our client’s portfolio contains mainly niche, value-added products, which are complex to manufacture.
  • With a strong pipeline of new product development, the Company continues to grow in each of their key areas

What you will be doing:

  • Review departmental training requirements and ensure they are in-line with requirements.
  • Assure a safe and compliant workplace by adhering to all EH&S procedures and reporting any health and safety issues as required.
  • Comply with all training requirements as required by the job function.
  • Liaise with other departments & ensure supporting data generated and provided in a timely manner
  • Optimize reportee headcount resources and recruitment at all times. Ensure suitably organized and managed QA and compliance team is in place in line with the associated responsibilities.
  • Investigating ways to reduce waste and increase efficiency for the Quality systems in Quality Operations
  • Coordinate and plan batch record review and QP Certification activities.
  • QP Release site Batches as Assigned
  • Responsible for the Site Validation Master Plan and associated execution
  • Manage and approve Validation templates, SOP’s and work instructions.
  • Responsibility for Validation planning and execution for all site activities
  • Support all operational and agreed project targets as agreed with management team.
  • Responsibility for setting and reporting of Site Quality KPl's (QTM)
  • Manage the tracking and completion of Active Pharmaceutical ingredient (API) manufacturing site audits as well as review of reports.
  • Responsibility for maintaining and improving vendor approval process.
  • Responsibility for achievement of site objectives.
  • Responsibility for Site Procedure / Software/Equipment/ and approval.
  • Manage monitoring of Site API CEP revisions and determine validation requirement for new versions
  • Provide management oversight and ownership of the system used to initiate, track and investigate non-conformances and PIRs to Good Manufacturing Practice (GMP) and Market authorisation.
  • Ensure an appropriate program is in place to manage Product Quality Reviews (PQRs) and that these are consistently completed fully and on-time.
  • Manage the review and approval of Master Batch Records (Batch Manufacturing & Packing records, Validation/Stability Protocols and Report, Finished Product Specifications and End of Shelf Life specifications).
  • Track and investigate any assigned investigations and complete CAPA actions to agreed timeframes.
  • Manage and Co-ordinate key site quality processes including Document Control, internal audit Program and PIR’s
  • Responsibility for management of internal/external customers and competent authority audits relating to Site.

What you need to apply:

  • A minimum of 5 years’ experience at Quality Management level.
  • Scientific degree (ideally pharmacy, pharmaceutical sciences, chemistry or related) and QP Qualified
  • Strong leadership/team management skills and experience.
  • Ability to prioritise, demonstrating good time management skills.
  • Excellent attention to detail, with the ability to work accurately in a busy and demanding environment.
Company Info
Team Horizon
1 Cedar Crescent, Cedar Park, Westport, Co. Mayo
Westport, Ireland
Phone: +353 98 50600
Web Site: http://www.teamhorizon.ie
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