QC Analyst

QC ANALYST with Dissolution Responsibilities DEPARTMENT: QUALITY REPORTING TO: QUALITY CONTROL MANAGER HOURS 40 hours per week Monday to Friday MAIN

DUTIES AND RESPONSIBILITIES:

The post holder will sample and test materials and commercial products to current regulatory requirements and assist with dissolution activities.

JOB PURPOSE:

The purpose of this job is to ensure the required analytical testing is carried out accurately as required by the relevant regulatory authority. GENERAL DUTIES Ensure that the equipment they use for sampling and testing of starting materials, intermediates and finished products and for monitoring environmental conditions for GMP manufacture is calibrated and used according to approved procedure. Sample and test starting materials, intermediates and finished products according to approved methods.

Prepare dissolution media, fill dissolution flasks and perform dissolution profiling of finished product batches. Validate test methods according to approved protocols. Complete and endorse all quality records to demonstrate that all the required sampling and testing procedures were actually carried out. Assist in the investigation of any out-of-trend or out-of-specification results and planned or unplanned deviations. Review data generated to ensure the continued accuracy of reported results and product compliance.

Prepare and amend procedures and batch documentation to ensure compliance with the Quality System. Manage their time so as to accommodate the tasks allocated to them on a daily basis. Undertake any other duties, which may be assigned by Management. A full job description is available on request ESSENTIAL CRITERIA:
Chemistry (or closely related) degree HPLC methodology and techniques Proficiency in Microsoft Office, particularly?

Word and Excel Must be able to work individually and as part of a team. Right to work in the UK. DESIRABLE CRITERIA:
Previous experience in a quality control laboratory (pharmaceutical preferred) Knowledge and understanding of the development and validation of HPLC and GC methods. Knowledge and understanding of GMP aspects of laboratory software applications. Good interpersonal skills. BENEFITS:
Company sick pay Length of service awards Discretionary bonus scheme Health care plan On site parking Cycle to work scheme 34 day leave per year inclusive of public holidays (FTE) Wedding leave Competitive salary Applicants must have the right to work in the UK