QC Analyst II

3 weeks ago

Dublin, Dublin City, Ireland Bimeda, Inc. Full time

Reporting to the QC Supervisor, the role is pivotal in conducting comprehensive chemical analysis, ensuring compliance with cGMP, SOPs, and maintaining Bimeda quality standards. Exceptional attention to detail and a drive for efficiency will be required, with a consistent and accurate approach to testing and documentation whilst adhering to all aspects of company and industry cGMPs. The analyst actively contributes to the writing and review of laboratory reports, investigations, deviations, and change controls, SOP and SAMs. Additionally, the role involves supporting various aspects of the QC Lab operation, including equipment calibration, stock replenishment, and purchasing within budget constraints. The Analyst Level 2 collaborates with internal and external stakeholders under the guidance of the QC Supervisor. This role is a central part of the QC laboratory operation and supports the wider compliance and quality teams with a common goal for continuous improvement and achieving the company's business strategy aligned with our Vision, Mission and values.

Key Role Specific Requirements:

Conduct raw material, finished product, in-process, stability, and water testing in accordance with SOPs and SAM, adhering to Good Laboratory Practices (GLP) principles, while meeting assigned test schedules.

Notify the Laboratory Supervisor or Senior Analyst promptly of any issues with methods, equipment, sourcing of materials, Out of Specification (OOS), Out of Trend (OOT), etc., that might impact testing timelines.

Write/review SOPs, SAMs, and FP/RM specifications.

Facilitate laboratory investigations, CAPAs, Deviations, and change controls in line with GDP as required.

Ensure timely completion of laboratory investigation reports and deviations through the non-conformance procedures.

Maintain records to GDP in a timely manner, e.g., Lab Notebooks.

Support the maintenance of the equipment calibration schedule.

Keep the workspace free of hazards and maintain it in accordance with GLP, practicing 5S daily, conducting stock checks, and adhering to housekeeping standards.

Review FP, IP, RM, and stability testing, trend results, issue batch cards, and test certs.

Actively participate in continuous improvement initiatives and seek opportunities for right-first-time practices.

Serve as the point of contact and SME for project work (e.g., method transfer, equipment qualification) based on business needs.

Provide technical guidance and apply critical thinking to help resolve technical issues.

Support the training of new employees and QC junior analysts on technical aspects.

Manage and contribute to achieving department productivity and quality goals.

Please note that this job description is not exhaustive, and the role holder may be required to undertake other relevant duties commensurate with the grading of the post. Activities may be subject to amendment over time as the role develops and/or priorities and requirements evolve.

Competencies Required for the Role:

FOSTERING COLLABORATION/TEAMWORK - Demonstrates the ability to work collaboratively with others, particularly in intellectual activities; Shows the ability to bring groups together effectively; Builds partnerships for global performance. Respects others. Guiding and mentoring junior analysts, leading projects, and sharing expertise with the team.

INITIATIVE - Identifying what needs to be done and doing it before being asked or before the situation requires it. A commitment to staying updated with the latest advancements in chemical analysis, technologies, and methodologies.

ADAPTABILITY: The ability to adapt to changes in the work environment, approach challenges with flexibility, and adjust strategies to achieve optimal results. Demonstrates resilience in the face of unexpected obstacles or changing priorities.

PROBLEM-SOLVING: Addressing chemical challenges by utilizing critical thinking and troubleshooting skills. Demonstrates the ability to assess information critically and suggest practical solutions. Precision and accuracy in conducting experiments, analyzing data, and interpreting results remain pivotal in chemical analysis.

COMMUNICATION: Written and Verbal Communication: The ability to write clear, concise, and comprehensive reports, documentation, and emails. Effectively communicating involved findings to technical and non-technical stakeholders with proficiency in both written and spoken expression.

Other Requirements:

  • Bachelor's Degree within a Scientific Discipline essential
  • Minimum 2 years' experience in GMP environment within a pharmaceutical environment.
  • Strong HPLC knowledge and other techniques as UV, TLC, KF, Titration.
  • Excellent technical writing skills.
  • Good understanding of root cause for LIR and deviation analysis and its application.

Optimal

  • Knowledge Dissolution, atomic absorption, GC, uPLC, HPLC, PSD

Bimeda is a leading global innovator, manufacturer and marketer of veterinary pharmaceuticals and animal health products and has over half a century's experience in providing science-driven solutions to optimize the health, wellbeing and productivity of the world's animals.

Bimeda's global innovation program sees six state-of-the art R&D centers across four continents collaborate on an enviable product development pipeline which anticipates the ever-evolving needs of the animal health industry. Bimeda's nine manufacturing facilities across seven countries allow the company to manufacture a broad range of preventative, curative and nutritional products including sterile injectables, vaccinations, nutritional boluses, feed additives, tablets, water-soluble powders, pastes and non-sterile liquids. Globally, the company focuses on the development, manufacture and commercialization of quality Bimeda-branded products while also being the partner of choice for contract manufacturing and R&D services for prominent companies within the animal health industry. Your application to us; assumes you have read and agree with our privacy policy More Info at About Us

Bimeda is a leading global manufacturer, marketer and distributor of animal health products and veterinary pharmaceuticals. Through ongoing expansion and strategic acquisition, Bimeda has established markets in more than eighty countries worldwide and has R&D, manufacturing and distribution capabilities across Europe, North America, South America, Africa, Asia and Australasia.

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