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Senior QC Systems Technical Specialist (1 year FTC) | HERTFORDSHIRE | Competitive SalaryBlackfield Associates are currently supporting a global pharmaceutical manufacturing organisation at their site based in the Hertfordshire area, to recruit for a Senior QC Systems Technical Specialist to join the organisation initially on a 1 year FTC basis.
The position has been created to support the implementation of a new LIMS system.You will provide expert technical support for QC laboratory electronic systems (LIMS, CDS), manage master data, resolve system issues, and ensure compliance with GMP and Data Integrity standards during this critical project.Key Responsibilities:
Manage and maintain QC electronic system data, particularly in the new LIMS implementation.
Troubleshoot system issues and support system enhancements.
Assist in the deployment, validation, and qualification of new systems.
Create and update SOPs and training materials.
Ensure compliance with regulatory and internal procedures.
Collaborate with internal teams and external vendors.
Support continuous improvement initiatives.
Skills and Qualifications:
Degree in a science discipline or equivalent experience.
At least 2 years' experience with LIMS/CDS in a QC setting.
Strong knowledge of GMP guidelines and data integrity.
Excellent communication and problem-solving skills.
Ability to work independently and manage multiple tasks.
STR Limited is acting as an Employment Agency in relation to this vacancy. ....Read more...
Type: Permanent Location: Hertfordshire, England
Duration: 12-months
Posted: 2024-10-10 15:43:15
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We are currently looking for an Associate Director, QC Stability to join a leading Biopharmaceutical company based in the Oxford.
As the Associate Director, QC Stability you will be responsible for setting up and maintaining a compliant stability program and regulatory submissions in both clinical and commercial settings.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Associate Director, QC Stability will be varied however the key duties and responsibilities are as follows:
1.
Oversee routine and non-routine stability studies, ensuring all data reports and documentation to support regulatory submissions are available on schedule.
2.
Manage and maintain a compliant stability program, including sample management, identifying stability studies, authoring stability protocols and reports, and maintaining trending of all stability activities.
3.
Provide technical expertise for laboratory investigations, troubleshooting assays, and ensuring acceptably low invalid rates.
4.
Lead the QC Stability team, including recruitment, leadership, and direction, as well as managing external vendors and contract testing facilities.
ROLE REQUIREMENTS:
To be successful in your application to this exciting opportunity as the Associate Director, QC Stability we are looking to identify the following on your profile and past history:
1.
Relevant degree in Chemistry, Biochemistry, Microbiology, or a related science.
2.
Extensive industry experience in a GLP/GMP-regulated environment, with a focus on laboratory-based testing and management.
3.
A working knowledge and practical experience with stability testing, regulatory submissions, and continuous improvement processes.
Key Words: Associate Director | QC Stability | Biopharmaceutical | Stability program | Regulatory submissions | Clinical | Commercial | GLP | GMP | Laboratory testing | Continuous improvement | Quality Control | QC |
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer.
We welcome applications from anyone who meets the role requirements.
HRS exclusively supports the STEM sectors, combining recruitment expertise with scientific knowledge to help you advance your career. ....Read more...
Type: Permanent Location: Oxford,England
Start: 10/10/2024
Salary / Rate: Competitive
Posted: 2024-10-10 11:16:05
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REGULATORY COMPLIANCE OFFICER
BELPER - HYBRID
UPTO 50,000 + EXCELLENT BENEFITS
THE OPPORTUNITY:
Get Recruited are recruiting on behalf of a global manufacturing company.
As the regulatory compliance officer you will be responsible for the compliance in the business.
Including the development and management of product SDS and regulatory compliance with applicable UK and EU regulations.
THE ROLE:
Monitor and interpret European regulations and guidelines relevant to products.
Ensure that all documentation meets regulatory requirements before submission.
Advising logistics team on compliance with dangerous goods legislation for transportation of goods.
Monitoring currently used chemicals for risk analysis on future regulatory actions or restrictions.
International regulations.
Reviewing safety data sheets.
Collaborate with R&D teams on regulatory review of new material or product developments.
Coordinate with internal teams to gather necessary data and documentation for submissions.
Develop and maintain regulatory policies and procedures.
THE PERSON:
Bachelors degree in Chemistry, Polymer Science, Toxicology or related field.
Experience in chemical, pharmaceuticals, veterinary, life sciences, manufacturing, construction, food, farming, toxicology etc.
Experience in regulatory compliance desired.
Relevant experience in regulatory compliance.
Excellent communication skills.
Able to communicate with colleagues across UK, Europe and US.
Get Recruited is acting as an Employment Agency in relation to this vacancy. ....Read more...
Type: Permanent Location: Belper, England
Start: ASAP
Salary / Rate: £40000.00 - £50000.00 per annum + EXCELLENT BENEFITS + CULTURE
Posted: 2024-10-09 17:41:39
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Are you experienced in Biotransformation Development and looking for an exciting new opportunity?
We are currently looking for a Biotransformation Development Lead to join a leading biopharmaceutical company based in either Berkshire, UK or Braine, Belgium.
As the Biotransformation Development Lead, you will be responsible for contributing to development and drug discovery projects in immunology and neuroscience therapeutic areas.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Biotransformation Development Lead will be varied however the key duties and responsibilities are as follows:
1.
Planning, performing, and interpreting metabolite profiling studies up to and including human ADME studies for regulatory submissions, including MIST evaluation.
2.
Planning and coordinating outsourced metabolite profiling studies in partnership with Contract Research Organisations.
3.
Providing guidance in line with regulatory requirements and applying this to biotransformation strategies.
4.
Generating, reporting, and communicating metabolic profiles in different biological matrices from in vitro and/or in vivo studies, including active and reactive metabolites by interpretation of mass spectral data.
ROLE REQUIREMENTS:
To be successful in your application to this exciting role as the Biotransformation Development Lead, we are looking to identify the following on your profile and past history:
1.
Relevant degree in Biotransformation, DMPK, or related areas with analytical chemistry experience.
2.
Extensive industry experience in biotransformation and metabolism, particularly in supporting preclinical and clinical leads.
3.
A working knowledge and practical experience in metabolite identification experience in LC/MS, bioanalytical chemistry and enzymology as well as strong knowledge of international regulatory principles and guidelines regarding human metabolites with particular emphasis on MIST.
Key Words: /Biotransformation/ /Development Lead/ /Pharmaceutical/ /Drug Discovery/ /Immunology/ /Neuroscience/ /Metabolite Profiling/ /ADME Studies/ /DMPK/ /Enzymology/
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer.
We welcome applications for any applicant who fulfil the role requirements for this position.
HRS is a company exclusively supporting the science and technology sectors, and is made up of a collaboration of recruitment professionals and scientists.
We look forward to helping you with your next career moves. ....Read more...
Type: Permanent Location: Berkshire,England
Start: 09/10/2024
Salary / Rate: Dependent on experience
Posted: 2024-10-09 17:25:40
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We are currently looking for a QA Batch Release Officer to join a leading pharmaceutical company based in the Hertfordshire area.
As the Batch Release Officer, you will be responsible for ensuring the seamless review and preparation of manufacturing batch records for QP disposition.
This role offers a unique chance to play a pivotal part in maintaining the highest standards of quality and patient safety.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Batch Release Officer will be varied however the key duties and responsibilities are as follows:
1.
Serve as the primary QA contact for batch release and document review.
2.
Participate in daily updates for batch release priority and complete GMP reviews of batch documents.
3.
Assess deviations and changes related to batch review on behalf of the QP.
4.
Highlight significant GMP and patient safety concerns to supervisors or QPs as needed.
ROLE REQUIREMENTS:
To be successful in your application to this exciting role as the Batch Release Officer we are looking to identify the following on your profile and past history:
1.
Relevant degree in a science discipline or equivalent.
2.
Proven industry experience in a (bio) pharmaceutical, clean room, or manufacturing environment.
3.
A working knowledge and practical experience with documentation and quality management systems.
Key Words:
Batch Release Officer / Quality Assurance / Pharmaceutical / GMP / Batch Records / QP Disposition / Sterile Aseptic Filling / Quality Management Systems / Regulatory Audits / Continuous Improvement ....Read more...
Type: Permanent Location: Hertfordshire,England
Start: 08/10/2024
Salary / Rate: Dependent on experience
Posted: 2024-10-08 17:09:35
