Chief Analyst and Quality Controller

4 days left

Recruiter
Reacta Biotech Limited
Location
Deeside
Salary
From £45,000 to £50,000 per annum
Posted
06 Jul 2018
Closes
21 Jul 2018
ROLE: Direct Responsibilities REACTA BIOTECH QUALITY CONTROLLER · Approving specifications, sampling instructions, test methods and other quality control procedures; · Ensuring all necessary testing is undertaken on ingredients, packaging materials, and finished products; · Evaluating batch records and approving/rejecting ingredients, packaging materials, and finished products; · Approving and monitoring contract analysts; · Ensuring all necessary testing and validation is undertaken on ingredients, packaging materials, facility, processes and finished products. QUALITY CONTROL LABORATORY LEAD · Ensuring the qualification, maintenance and safe running of the laboratory and equipment; · Undertaking transfer of newly developed test methods in to routine QC testing, validating them to internationally recognised regulatory guidelines. · Managing the QA testing team and ensure their ongoing training as appropriate to the needs of the Reacta Biotech products; · Authorship and review of SOPs, Protocols and Risk Assessments, preparation and review of OOS investigations and deviation reports. · Ensuring that all test methods used in the QC Laboratory have been validated appropriately and that test results are recorded and checked. · Involvement in audits both from internal and external parties · Keep up to date with current literature, test method developments and regulatory requirements. · Manage testing laboratory and testing requirements in a cost effective and timely manner GENERAL · Perform above activities in-house and with collaborating bodies as required liaising closely with the Operations Director and Chief Scientific Officer. · As part of the performance of this role the postholder will be exposed to sensitive information that must be kept confidential during and after employment in line with Reacta Biotech processes and terms of employment; · Work towards the corporate goals of Reacta Biotech; · Comply with Health and Safety and GPD regulations. ESSENTIAL Skills and attributes: · MSc in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences or equivalent experience. · Experience of working within a pharmaceutical quality assurance laboratory and knowledge of different types of accreditation (UKAS 17025, pharma GLP) · An understanding of chemical food safety analysis and food matrix validation. · A working knowledge and practical experience with method development and validation of analytical techniques such as such as FT-IR, immunoassay, immunoblotting and electrophoresis, HPLC, UV, FTIR and LCMS · Excellent oral (including presentation) and written communication skills. · Excellent interpersonal skills and ability to develop and maintain relationships internally and externally to the business. · IT competent (e.g. Microsoft office) and statistical analysis of analytical QC data · Excellent organisational skills and the ability to work under their own initiative. · Dedication to the role and the business exhibited through attendance and a willingness and desire to learn and take part in areas and projects outside of the scope of the role. DESIRABLE SKILLS · Experience of working with biologicals · Application of chemometrics for analysis of FTIR data This job was originally posted as www.totaljobs.com/job/82019127

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