Job Description

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cold Room/Freezers -22degreesF/-6degrees C, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Will work with hazardous/toxic materials

Position Summary:

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Reporting to the QC Manager Chemistry, the role is responsible for writing laboratory procedures, transfer/verification/validation of methodology, and project work within the department to support manufacture and release of pharmaceutical raw materials, intermediates and products. The role contributes to building and maintaining QC lab cGMP system, delivers analytical solution to clients through specific method qualification and validation strategies while ensuring timely delivery for projects. The role will include performing testing for incoming materials, in-process products and DS testing, etc.

Responsibilities:

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To support new equipment qualification, lab computerized system and chemistry lab set up To perform transfer/verification/validation of laboratory procedures within the team where required To prepare technical documentation including but not limited to protocols, analytical write-ups, standard operating procedures, specifications, investigations and reports. To perform analysis of incoming goods, intermediates and/or finished products (including HPLC and GC) under cGMP conditions for QC release or as part of stability studies. To review analytical and laboratory data within the department for accuracy, completeness and compliance with documented procedures. To perform planned preventative maintenance and performance calibrations on equipment. Management of QC chemical, reference standard and consumable stock levels To maintain own training records To communicate optimally with others on site Participate/contribute in Practical Process Improvement initiatives (PPI) or continuous improvement in the lab Support and encourage a "Quality Culture" and company 4i values throughout QC Ensure cGMP is applied in their area of work and align with cGMP in all areas of the business. To work with HSE, cGMP and 5S in mind at all times. Undertake ad-hoc activities that may be required by the business To support shift work (if necessary) in future

EH&S:

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Understand emergency procedures and align with safe systems of work. Ensure compliance with environment, health and safety and security policies and procedures, rules, signage and instructions at all times Ensure prompt reporting and investigation of all accidents, near misses and breaches of rules

Minimum Requirements/Qualifications:

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Degree in Chemistry or strongly related scientific field At least 2 years relevant industrial experience Ability to apply GMP regulations and other international guidelines to all aspects of the position. Ability to work independently and adhere to critical timelines * Excellent attention to detail