Quality Control/ ADL Analyst

About us

Bristol Laboratories Ltd is one of the leading and fastest growing pharmaceutical companies in the United Kingdom engaged in the development, manufacturing, marketing and distribution of generic medicines, as well as formulation brands. We have state-of-the art manufacturing facilities in Luton & Peterlee.

As a result of continued growth and expansion, we have an excellent opportunity to appoint Quality Control/ ADL Analyst in Luton & Peterlee.

Key Responsibilities:

* Testing, validation, stability & environmental monitoring (as per written procedure or as per applicable pharmacopeia) of all laboratory samples including raw materials, in-process and finished products.

* Recording all details appropriately & accurately during all stages of carrying out daily activities, including usage of laboratory chemicals.

* Operation, maintenance, calibration & trouble shooting of laboratory instruments, preparation and execution of instrument qualification and method validation protocols.

* Timely reporting of any non-conformance, instrument malfunction, accident or other abnormal occurrence to immediate superior.

* Analytical Method Development (Quality by Design), Validation and optimization of related substances, Assay, Dissolution.

* Planning, executing & reporting of regulatory queries, deficiency, and analytical method validation in accordance to the technical and regulatory guidance to meet the regulatory compliance.

* Responsible for Analytical Method Transfer.

* Perform method equivalency study (Compendial VS In-House method)

* Ensuring all GDP/cGMP/GLP and Health & Safety requirements are strictly adhered to and that SOP’s are followed at all times.

* Facilitate and participate in self inspections, internal quality audits, customer audits and regulatory inspections.

* Ensuring individual training record is kept up to date.

About you:

Requirements

* Academic achievement to minimum Graduate Degree level in a Science based discipline

* Firm understanding of cGMP/GLP/GDP guidelines in pharmaceuticals

* Excellent verbal/written communication and interpersonal skills

* Effective Time Management skills

* Competent computer skills (Microsoft Office)