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Job Description
Bringing a collaborative style, energy, knowledge, innovation and leadership to carry out the following:
Perform laboratory experiments and analyse test results required to deliver on project timelines.
Knowledge of or experience with the following would be an advantage:
Method validations, method transfers and equipment qualifications in a GMP environment.
Protein chemistry, and analytical techniques including aseptic technique, cell culture, chromatography, immunoassays, and spectrophotometry.
Cross-functional participation in continuous improvement initiatives, including method optimisation and troubleshooting.Provide support to new product introductions and technical transfers to and from the site, including new technologies.
Preparation of documentation, including protocols and reports, associated with the projects in accordance with GDP (good documentation practice) and site procedures.
Lead and participate in cross-functional projects and problem-solving teams for troubleshooting, and investigations across site. Supporting activities in the areas of cost reduction, process efficiency and operational excellence.
Prepare, review and approval of technical documents, procedures, CAPAs, change control, deviations, metrics, etc. Ensuring that all safety, quality and environmental compliance goals are achieved, including thoroughly investigating deviations and ensuring appropriate corrective actions are identified and implemented in full.
To excel in this role, you will more than likely have:
MSc/BSc. qualification (Science)
High personal integrity, credibility, and energy. Demonstrated ability to work as part of diverse teams in an inclusive manner. Demonstrated ability to be self-driven with respect to driving results and implementing identified improvement initiatives.
Previous experience in API or Drug Product, as well as an aptitude for problem solving in a technical environment are desirable.
Knowledge of validation science would be highly advantageous.
High level written and verbal communications with advanced PC skills, including proficiency in MS Office. Familiarity with systems including LIMS, EMDS (e.g. QualityDocs, MEDS), QMS would be an advantage.
A working knowledge of sample management and tracking, investigational reports including Root Cause Analysis, statistics, and a metric-driven approach to project management
Current Contingent Workers apply
*A job posting is effective until 11:59:59PM on the dayBEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the dayBEFOREthe job posting end date.
A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
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