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QC Associate 30074

  • Job reference: 932302
  • Location: Dublin South, Dublin
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Life Sciences, Quality, Compliance, Regulatory Affairs
  • Date posted: 24/11/2020

Orion Group Life Sciences have an exciting opportunity for a QC Associate for our Multinational Pharmaceutical client based in the South of Dublin area on a 12-month contract.


Job Purpose

This role will be responsible for leading, coordinating, facilitating, and undertaking activities pertaining to lab operations and compliance, with minimal supervision, acting as a role model for other lab colleagues. The role undertakes implementing continuous improvement projects and supporting a lean culture and Right First Time (RFT). The role also represents the QC unit by liaising with internal and external customers.

Main Responsibilities of the role

  • Experience in a wide variety of analytical techniques including but not limited to Ph, Appearance, Colour, Clarity, Sub Visible Particle testing, Osmolality, Moisture.
    * Plan and perform multiple, complex routine/ non-routine methods and procedures and a large variety of assays.
    * Participate in the peer review of analytical data.
    * Responsible for providing technical guidance and applying expertise and critical thinking to help to resolve technical issues.
    * Lead training of staff on technical aspects of job as required.
    * Develop, revise and implement procedures that comply with appropriate regulatory requirements.
    * Qualification of analytical equipment and related testing functions.
    * Participate in Analytical Method Transfers
    * Compliance with Standard Operating Procedures and Registered specifications.
    * Ensure the laboratory is operated in a safe manner
    * Maintain quality systems within the QC laboratories to ensure ongoing compliance to cGLP and cGMP.
    * Ensure timely completion of Laboratory Investigations and Deviations
    * Participate in the generation and update of SOP's, trend data, investigations, Deviations, validation protocols, reports, method validation/verifications and equipment qualifications.
    * Participate in regulatory agency inspections as required.
    * Plan and implement procedures and systems to maximise operating efficiency.
    * Manage and contribute to the achievements of department productivity and quality goals.

Desired Experience and Background of the successful candidate

Qualifications:
* Excellent written and verbal communication skills
* Experience with TrackWise, Change Control Systems and EDMQ an advantage
* Knowledge of applicable Regulatory requirements
* Experience with Regulatory inspections and interaction with inspectors is preferable
* Experience leading cross-functional teams
* Experience working with teams and influencing decision
* Skilled in the use of problem-solving tools/techniques

Knowledge and Experience:
* Hold a third level qualification (Degree) in Biology, Biotechnology or related discipline.
* Have 4-5 years of experience in a pharmaceutical/healthcare Laboratory.
* Strong background in General analytical chemistry techniques such as Appearance, Colour, Clarity, Ph, Sub Visible Particle testing, Osmolality, Moisture.
* Possess key competencies to include planning/organisation, problem solving, communication, teamwork, flexibility, coaching and motivating.

For more information on this role, call Kate O'Sullivan on +353 (0) 212063412 or email kate.osullivan@orioneng.com for a completely confidential chat about this role and other opportunities using the reference number: 932302
#pharmaceutical #pharma #multinational #QC #GMP



Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.

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