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QC (Senior)



Location:
Dublin South, Dublin
Salary:
Negotiable
Sector:
Pharma & Life Sciences, Quality & Regulatory
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This vacancy has now expired.

Our client, a Biopharmaceutical company is currently recruiting a QC (Senior) for a 12-month contract in Dublin.


QC (Senior)
Position Summary:
Under minimal supervision, responsible for one or more of the following activities in QC including analytical testing, characterization, method development, sample and data management and equipment maintenance.

  • Contributes to team by ensuring the quality of the tasks/services provided by self
  • Contributes to the completion of milestones associated with specific projects or activities within team


This role will support manufacturing operations, as such some extended hours and weekend work flexibility may be necessary as required.

Candidates must have:

  • 4 years extensive HPLC experience with Empower software
  • Peer to peer review experience
  • 3 years solid GMP pharma experience
  • Potential for shift cover
  • Experience and comfortable with general GMP IS systems, electric lab notebook, QMTS, LIMS.

Responsibilities:

  • With a high degree of technical flexibility, work across diverse areas within the lab
  • Plan and perform routine analyses with efficiency and accuracy.
  • Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of assays.
  • Report, evaluate, back-up/archive, trend and approve analytical data.
  • Troubleshoot, solve problems and communicate with stakeholders.
  • Initiate and/or implement changes in controlled documents.
  • Participate in audits, initiatives, and projects that may be departmental or organizational in scope.
  • Write protocols and perform assay validation and equipment qualification/ verification.
  • Introduce new techniques to the lab, including method transfers, reports, validations and protocols.


Knowledge:

  • Understanding and application of principles, concepts, theories and standards of GMP QC analytical laboratories. Deepens technical knowledge through exposure and continuous learning
  • Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery
  • Experience in a wide variety of analytical techniques including but not limited to HPLC and Capillary Electrophoresis.

Skills:

  • Take initiative to identify and drive improvements
  • Excellent verbal and written communication skillsStrong Technical writing skills for GMP documentation (e.g. investigations, procedures, change controls)
  • Presentation skills
  • Escalate issues professionally and on a timely basis
  • Decision Making skills
  • Teamwork and Coaching others
  • Negotiation and Influence skills
  • Problem solving skillsApplies research, information gathering, analytical, and interpretation skills to problems of diverse scopeEnsures compliance within regulatory environment
  • Develops solutions to technical problems of moderate complexity
  • Screens, categorizes, evaluates, reconciles, reports, and resolves data integrity issues
  • Interprets generally defined practices and methods
  • Able to use statistical analysis tools to perform data trending and evaluation
  • Project Management and organizational skills, including ability to follow assignments through to completion


Qualifications and Experience:
ESSENTIAL:

  • Bachelor's degree in a science discipline.
  • 5+ years of biopharmaceutical QC experience or related quality control or GMP laboratory experience in the pharmaceutical or medical device industry.
  • Experience with regulatory compliance in GMP manufacturing and testing of pharmaceutical products.
  • Chemistry experience is preferable
  • HPLC experience is essential

DESIRABLE:

  • Experience in development/ and or evolution of GMP systems.
  • Operational experience.
  • Experience in leading a project or team
  • Experience in auditing of external suppliers, contractors and vendors.



Berkley Engineering is a specialist recruitment consultancy which recruits pharmaceutical, medical device and clinical professionals throughout Ireland, Europe, Asia and Australia.
For more information and to see all the Engineering Jobs available go to http://www.berkley-group.com

To apply: If you would like to discuss this vacancy further or to discuss your career and other job options in confidence, please telephone Tony Tynan on +353 (0)21 4289610 or send your CV to ttynan@berkley-group.com

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