reviewer qc & microbiology.

Defines and implements microbiological quality control techniques in order to verify the quality of raw materials, intermediate, final product, water and environmental monitoring, as well as any other analytical services relevant to our client base and according to regulatory requirements. Manage and control microbiological Quality Control activities in accordance with identified quality assurance standards, company procedures, client specifications, contract requirements, and regulatory guidelines.

Proficiency level description:

Apply conceptual knowledge in the discipline;
Exercise judgement and apply analysis to identify and solve problems;
Typically work within established procedures, potentially introducing new methodologies and knowledge;
Work under moderate supervision, work is reviewed for soundness of technical judgement, and accuracy.

Main responsibilities:

Prepare changes to QC procedures or analytical methods for onwards approval and implementation;
Accurately use and maintain all microbiology laboratory information systems, participating in the implementation of lab systems improvements as required;
Prepare protocols, reports, documentation and review records to ensure compliance with cGMP and HSEE standards;
Initiate events and deviations in the CAPA system in accordance with the required timeframes;
In partnership with appropriate colleagues, participate in root-cause investigations and complete relevant section/s of the event or deviation within the required timeframe;
Complete or support the completion/close out of OOS/OOT laboratory deviation investigations and QC incidents;
Monitor progress and follow-up corrective and preventative actions;
Ensure own work is done safely and with high-quality, alerting ascending colleagues to any potential risks, discrepancies, deviations or non-conformance in accordance with company internal procedures;
Support the compilation of audit responses for QC;
Apply and develop knowledge of Quality Control related issues (e.g. instrumentation, deviation, stability) and participate in area processes, procedures and projects with the guidance of more senior colleagues;
Experience in analytical techniques and instrumentation, such as gas (GC) and high-performance liquid chromatography (HPLC) amongst others;
Software Empower;
Perform to ensure all assigned tasks are delivered on time, safely, efficiently, reliably and in a cost-effective manner;
Execute professional activities in compliance with GMP and HSE guidelines, internal and external requirements as well as promote the implementation and maintenance of company olicies, systems and procedures;
Undertake any additional tasks commensurate with the role as and when required;
Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with environmental, health & safety rules/procedures, regulations and codes of practice;
Must have the Knowledge, Experience and Skills to conduct their tasks in accordance with the rules and procedures set down.
 

University, or equivalent, qualification in Chemistry, Chemical Engineering, Pharmaceutical Sciences or similar Chemistry, Biochemistry or Health Sciences field (mandatory);
Requires educational / training experience in a QC microbiology laboratory environment (desired);
Analytical techniques and instrumentation - GC and HPLC;
Software Empower;
Training of GMP and ICH standards (desired);
Knowledge of analytical theory and microbiological techniques;
Fluency in English is a requirement;
Computer literate with good working knowledge of the MS Office package.