Manage projects and/or processes and allocated resources to support departmental
projects and objectives according to agreed timelines and standards and assure
compliance with GMP is maintained
- Manage portfolio of projects, support a discipline and/or provide a service. If applicable, may provide functional expertise in area of responsibility.
- Review and recommend disposition of deliverables (e.g. procedures, records, third party work, contractors, clinical trial material, components) and related tools (e.g. IT, document systems, training tools, facility validation) to ensure
- GMP compliance. With training and specific delegation may also approve relevant deliverables.
- Support project related activities (e.g. interpret results, evaluate data, draw
- relevant conclusions).
- Perform inspections and audits as required
- Contribute to the evaluation of new QA tools.
- Write GMP relevant documents in own area of responsibility (e.g, SOPs with
- global applicability).
- Supervise 0-3 direct/indirect reports or a team.
- Provide support to line functions in GMP compliance related issues (e.g.
- training, document management) .
- Meet internal and external guidelines regarding quality and safety (quality
- manuals, regulatory cGMP guidelines, health authority guidance’s, SOPs, HSE,
- etc). Promote and enforce compliance to guidelines.. If managing associates,
- ensure same for them.
- Support project management functions as a sub-team member or in
- preparation for a PAI.
- Lead and support direct reports in line with values and behaviour
- including objectives setting, performance evaluations, development planning
- and participate in recruiting process.
Qualifications and Experience:
- Minimum: Technician with continuing education (EU) or BS/MS (US) or equivalent
Basic degree in scientific or relevant discipline (BS or equivalent)
- Desirable: Advanced degree in scientific or relevant discipline (MS or equivalent)
- Good knowledge in English (oral and written) required; fluent in site-language desirable
- At least 2 years of relevant experience.
- Ability to negotiate and communicate .
- Sound scientific, technical and regulatory knowledge in a specific area.
of safety and environmental regulations and guidelines.
- Good knowledge of drug development .
- Good organizational skills.
- Good ability to analyze and evaluate GMP compliance