Senior Pharmaceutical Development Analyst
Negotiable
Northern Ireland
Permanent
Science, Pharma & Food
Job Description
Are you a dynamic and experienced scientist looking to make a significant impact in the field of pharmaceutical development? MCS Group are seeking to recruit a Pharmaceutical Development Scientist for our clients R&D Team.
In this role, you will collaborate with a diverse group of talented analysts to drive innovation and ensure the highest quality standards in the clients products.
Role Overview:
As a Pharmaceutical Development Senior Analyst, you will play a pivotal role in the Research & Development department. Your responsibilities will span from overseeing analytical testing for new product launches to supporting existing finished product methods. You will guide the development, validation, and transfer of methods, ensuring compliance with regulatory standards and maintaining the highest level of data integrity. Your role will require effective coordination with the Quality Assurance team to ensure a seamless work flow and exceptional data output.
Key Responsibilities:
* Train and mentor new and existing staff
* Monitor laboratory activities and personnel to ensure strict adherence to GMP regulations and audit readiness.
* Lead analytical method development, validation, and transfer for stability indicating methods.
* Conduct thorough reviews of project raw data, adhering to relevant guidelines and regulatory standards.
* Collaborate with Team Leaders to address analytical challenges and expedite project timelines.
* Interface with Quality Assurance to review raw data and resolve queries, driving continuous quality improvement.
* Provide technical input to troubleshoot analytical issues across the organisation.
* Coordinate weekly task scheduling for analysts to meet project timelines.
* Oversee trending of analytical data and lead investigations into out-of-specification results.
* Identify opportunities for laboratory improvements and take ownership of implementing changes.
* Contribute to the creation and review of technical documents, SOPs, and reports.
* Maintain a safe laboratory environment and ensure compliance with health and safety regulations.
* Participate in the review of departmental metrics to drive continuous improvement.
* Stay updated with industry guidelines and best practices for stability and process validation studies.
Essential Criteria:
* A degree in a science-related discipline or equivalent qualification.
* A minimum of two years' experience working in a cGMP environment.
* Proficiency in HPLC, UPLC, GC, and practical wet chemistry techniques.
* Experience in GMP data review.
* Familiarity with VICH guidance for Method Validation, Process Validation, and Stability studies.
To speak in absolute confidence about this opportunity please send an up to date CV via the link provided or contact Kelly Eccles Senior Recruitment Consultant at MCS Group.
Even if this position is not right for you, we may have others that are. Please visit MCS Group to view a wide selection of our current jobs www.mcsgroup.jobs
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