Basic Qualifications
School: Grade 12
Post School
Graduate qualification (or equivalent experience) in a scientific discipline.
BSc in chemistry or National Diploma in analytical chemistry.
Experience
Good problem solving and analytical reasoning skills.
Good understanding of key analytical techniques (wet chemistry, spectrophotometry, chromatography)
Thorough understanding of GMP, safety and other GSK regulatory requirements.
Understand the manufacturing and testing processes for drug substances and intermediates.
Well developed verbal, numeric and presentation skills, computer literacy, competent in Microsoft packages.
Knowledge of specialist IT systems for laboratories, e.g. Empower 3, at least 3 years experience
Details
Preferred qualifications:
Job Purpose
Tests compliance of products on stability programmes to specification using various analytical techniques.
Performs peer review for analytical results.
High analytical / product complexity.
Essential Job Responsibilities
High range of experience and technical expertise required.
Test products on Stability programs according to Protocols.
Analyses a large range of product types – tablets, capsules, creams, ointments, creams, liquids, suppositories, pastes and powders
Develops Analytical Methods using acquired knowledge under direction of Manager/Cell leader.
Validates analytical methods according to protocols.
Prepares analytical method validation protocols.
Carries out analytical method transfers as per protocols.
Tests samples for Process Validation and Cleaning Validation as per Protocols.
Performs `Peer Review’ of analytical data as required.
Implements the OOS procedure for problematic results.
Applies Good Laboratory Practice principles, 6S and EHS standards.
Analyses QC product samples as requested by Manager/Cell leader.
Partakes in continuous improvement activities – Advocate projects.
Performs L1 audits
Closes out CAPAs, NCs and CCRs.
Compliance GLP & QMS
Complies with the requirements of Good Laboratory Practice and the requirements of the applicable GSK QMS Policies.
Ehs
Complies with EHS standards and guidelines and Site EHS SOPs.
Complies with SOPs wrt safe use of chemicals/reagents, glassware, analytical procedures and the use of PPE.
Operational Excellence
Partakes in continuous improvement activities to reduce costs, increase productivity and improve quality.
Participates in, projects to continually improve processes – LeanLab, OE and Leansigma methodology

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