Are you a QC Analyst with one or more years' experience working within a pharmaceutical or biopharmaceutical lab performing HPLC or UPLC daily. This is a pivotal role in terms of execution and delivery for the business and supporting test and release of priority lots. The role supports activities related to structured problem solving, technical support for laboratory investigations and support teams such as safety, 5S, good lab practices and training.
Knowledge, Experience and Skills:
- Chromatographic separations experience in UPLC/HPLC and Empower
- Technical writing (protocols, reports, procedures)
- The ability to analyse data with a logical approach to problem solving and troubleshooting
- Excellent spoken and written communication skill
- Proficient in Microsoft office
- Working knowledge of GMPs, GLPs, pharmacopoeial, and regulatory requirements for testing and validation pertaining to the pharmaceutical industry is required.
Duties include:
- Supports testing of finished product across a variety of techniques for the solid oral dosage, sterile and biologic product portfolio.
- Review of analytical data and documentation to ensure compliance to appropriate specifications and protocols.
- Supports reviews and investigations for out- of trends/out-of specifications.
- Participates in validation and commercial/developmental manufacturing activities
- Troubleshoots standard instrumentation/test methods
- Coordinates waste management, LEAN/Operational excellence and 5S efforts as required.
- Participate in QC and cross-functional projects as required.
- Assists in the training of QC staff.
- Writes and revises methods, specifications, and SOP's as needed.
Education & Experience
- BSc degree in analytical Biochemistry or equivalent
- Prior experience in pharmaceutical industry is preferred
- Resilient profile with the ability to deliver in an ambiguous environment
- Ability to engage and manage multiple stakeholders to achieve the objective
- Curious with learning agility
- Operationally excellent
- Organised with systematic approach to prioritisation
- Process orientated to achieve the business objective