- You report to the Launch workstream lead and work closely with the other workstreams (Tech Transfer, Manufacturing, Quality, ...) and with suppliers to collect, evaluate and document information about materials with the aim of qualifying the materials and / or suppliers for the intended use.
- It is recommended that you have strong communication skills to find the best possible raw material match in discussions with suppliers and procurement, raw materials that meet our quality requirements and the specifications determined in the developed process.
- You will also need to use your strong communication skills in discussions with our R&D and MSAT colleagues.
- Providing well-founded advise taking the cGMP regulations & company guidelines into account and even lend a helping hand in writing material spec sheets and Quality Agreements, various assessments and reports, ... and following up a detailed planning are part of your tasks.
- It is your responsibility, together with the Launch SC Workstream Lead, to monitor the progress of the project and make required adjustments were needed making sure we absolutely adhere to the set timelines.
- All this must be done according to predefined procedures, company standards and cGMP regulations.
jobdetails
volgende stappen
randstad operational
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jobdetails
- You report to the Launch workstream lead and work closely with the other workstreams (Tech Transfer, Manufacturing, Quality, ...) and with suppliers to collect, evaluate and document information about materials with the aim of qualifying the materials and / or suppliers for the intended use.
- It is recommended that you have strong communication skills to find the best possible raw material match in discussions with suppliers and procurement, raw materials that meet our quality requirements and the specifications determined in the developed process.
- You will also need to use your strong communication skills in discussions with our R&D and MSAT colleagues.
- Providing well-founded advise taking the cGMP regulations & company guidelines into account and even lend a helping hand in writing material spec sheets and Quality Agreements, various assessments and reports, ... and following up a detailed planning are part of your tasks.
- It is your responsibility, together with the Launch SC Workstream Lead, to monitor the progress of the project and make required adjustments were needed making sure we absolutely adhere to the set timelines.
- All this must be done according to predefined procedures, company standards and cGMP regulations.
belangrijkste verantwoordelijkheden
- Follow-up of project timelines in close cooperation with the Launch SC Workstream Lead
- Aligning needs with internal users and gathering information from internal contacts, suppliers or other resources.
- Determining the qualification approach for new materials, services and suppliers, taking into account compendial and other regulatory requirements
- Evaluating the qualification results (supplier documentation package, analytical test results, audit reports,....) and if needed support in writing qualification reports
- You are responsible for planning and following up on Method Validation activities performed by contract lab(s), incl. Review & Approval of analytical Method Validation protocols and reports
- Provide advise & lend a helping hand in writing Material Spec Sheets, Quality Agreements and other deliverables
- Evaluating and resolving discrepancies (such as Out of Specification results) and issues during qualification
ervaring
Mediorkwalificatie
- Master in a scientific direction, or equivalent through experience
- Experience in project lead role is an advantage
- Min. 3-5 years relevant experience in a Supply Chain or Quality environment
- Knowledge of cGMP in a regulated environment
- Documentation/administration doesn't scare you
- You know your way around common Pharmacopoeia (EP, USP, JP, ChP)
- Prior experience with analytical Method Validation /Method Transfer is a must
- You are a go-getter with strong analytical and problem-solving abilities
- You take the initiative. You are result-oriented, flexible and can work independently within the set objectives
- You can motivate the team and ensure the set timelines are respected
- You have good social and communication skills and you speak and write Dutch and English fluently.
voordelen
As a consultant with Randstad Professional, you enjoy an attractive package:
- Competitive gross salary including a 13th-month bonus and double holiday pay
- Net monthly allowance
- Meal vouchers & eco-vouchers
- Choice between a company car with a fuel/charging card (SalSa plan) or a mileage allowance for using your own car
- Hospitalization insurance from day one + optional outpatient insurance (incl. dental care)
- Group insurance (pension scheme)
- Cafeteria plan (Flex Income Plan)
- 4 weeks of statutory leave + 12 ADV days (reduced working hours) + seniority leave
- Option to work from home (depending on the project)
- 'Benefits at Work' discount platform
- Referral bonus for hires made through your network
- Personal follow-up by an account manager, HR/L&D support, and access to training, learning tools, and certifications
- Networking events and internal activities to stay connected with colleagues and the organization
Prefer to work as a freelance consultant?
- We pay your invoices on time and accurately (30-day terms)
- Our team of recruiters and account managers is invested in your career and provides close support
- We proactively look for your next challenge as your current project nears its end