- Ensures that all work is carried out in compliance with company Safety policies, Good Manufacturing Practices (GMP/GLP) and Standard Operating Procedures (SOPs).
- Author, review and execute to method transfer protocols for new product introduction and compendial validation
- Ability to work directly from the USP or EP pharmacopeia to write protocols and execute methods.
- Expertise with analytical tests utilizing HPLC/UPLC, GC, UV, IR, FTIR, KF and other laboratory instruments.
- Assess, compare and perform risk assessments for compendial method compliance according to USP, EP, and other regulations.
- Assess analytical methods and perform gap analysis on analytical method validations for NPI. Develop plan and timelines for method transfers, required improvements and justification with approval from team to ensure compliance.
- Conducts complex analytical (physical & chemical) testing of raw materials, in-process samples, finished products required for method transfer and validation.
- Reviews laboratory documentation in notebooks, attachments, chromatography software and specification sheets for accuracy, completeness and compliance with established SOPs, specifications and methods.
- Conducts the investigation of deviations, out of specification (OOS), and non-conformances. Writes reports as required.
- Verifies and processes analytical data for method transfer. Writes technical documents such as methods, specifications, SOPs, method validation protocols and reports, method transfer protocols and reports.
- Participates in general lab duties, including clean up, administration, logbook review and operations support.
- Other duties as assigned.
- 5-7 years in a Pharmaceutical Analytical testing lab & supporting stability programs
- B.Sc. in Chemistry, Biochemistry or related discipline
- Proficient in Analytical Wet Chemistry Lab experience using the following methods/equipment: titration, pH, Potency, Conductivity, Viscosity, TOC, UV, IR, GC, HPLC/UPLC assays
- Excellent communication skills with stakeholders, external partners and management.
- Knowledge of ICH and regulatory guidelines, pharmacopeia, and industry best practices for analytical method validation and transfer.
- Understanding of GMPs and requirements for working in GMP laboratories.
- Good investigational skills, including design of experiments and establishing appropriate criteria. Experience with statistical data analysis and software.
Core Behaviours, Skills & Abilities:
- High integrity. The right candidate ensures adherence to procedural guidance and raises any identified issues to the QC Supervisor.
- Excellent attention to detail – able to thoroughly document and review work, while consistently identifying discrepancies or errors.
- Committed to teamwork, and to achieving team targets.
- Motivated and challenges self by setting and achieving goals.
- Ability to organize and prioritize work.
- Excellent communication skills both verbally and written - expresses own views clearly and constructively & confirms understanding.
- Acts with purpose, urgency, reliability and professionalism.
- Engages in good change initiative (CI) behaviour - open to new ideas & identifies areas for improvement.
- Versatility to perform a wide variety of tasks, showing flexibility in work assignments and organization.
At Bimeda we are committed to fostering an inclusive, barrier-free and accessible environment. Part of this commitment includes arranging accommodations to ensure an equitable opportunity to participate in the recruitment and selection process. If you require an accommodation, we will work with you to meet your needs.
The job posting is available in an accessible format upon request by contacting the Human Resources Manager
Bimeda is a leading global innovator, manufacturer and marketer of veterinary pharmaceuticals and animal health products and has over half a century’s experience in providing science-driven solutions to optimise the health, wellbeing and productivity of the world’s animals.
Bimeda’s global innovation programme sees six state-of-the art R&D centres across four continents collaborate on an enviable product development pipeline which anticipates the ever-evolving needs of the animal health industry.
Bimeda’s nine manufacturing facilities across seven countries allow the company to manufacture a broad range of preventative, curative and nutritional products including sterile injectables, vaccinations, nutritional boluses, feed additives, tablets, water-soluble powders, pastes and non-sterile liquids.
Globally, the company focuses on the development, manufacture and commercialisation of quality Bimeda-branded products while also being the partner of choice for contract manufacturing and R&D services for prominent companies within the animal health industry.
More Info at www.bimedacareers.com