Description
Description
- The product is future 3CB bags produced by the Korean JW company (with fish emulsion).
- In order to sell the product in EU (as there is no mutual agreement between EU/Korea), release testing of Finish products is require for EU clearance
- Lessines QC Lab has been preferred to external lab (SGS, QA ) for financial considerations.
- Some of the testing methods are already available at Lessines lab (as already used for current 3CB portfolio). However, there are some specific and different ones currently used at JW that we would need to transfer to Lessines
Main skills:
o Chemical Engineer with a strong expertise in Analytical methods
o Experience in a QC lab
o Experience in validation
o Fluent in English
o Good communication skills and teamwork orientated
o EITHER Korean speaking OR has extensive previous experience in working with ASIAPAC based companies
More in depth job description:
Responsible for:
Participate to a variety of projects by conducting routine and non-routine testing, designing experiments, developing/evaluating/validating and/or transferring analytical methods without any assistance
Contribute to Baxter portfolio extension as senior analytical lead of complex and/or large size projects, anticipate requests from authorities to act pro-actively and support supervision with resources estimations.
Act as Subject Matter Expert (SME) in Specific Technique/Software (eg: Enoval/ Fusion/GC/HPLC/MS/)
Essential Duties and Responsibilities.
1. Perform laboratory testing in a qualified environment following procedures (equipment and analytical procedures) and local or global processes, with respect to timeline and planning assigned to the team.
2. Report to supervision any issue within area of work (out of trend, out of specification results, equipment issue or conflict in activities), propose solutions and participate in investigations whenever needed.
3. Review critically LNB and data (TA1) to ensure compliance with analytical methods, global and local procedures (GDP, quality system, etc)
4. Work with software in place (SIMS, LIMS, Equipments' software, development and statistical tools (e-noval, MVM, fusion, minitab)
5. As study director of request, ensure the purpose of the document is clearly understood, challenge the content (sample number, test to perform), ensure follow-up and discuss results.
6. Conduct request or compendia queries and proposed improvements to troubleshooting. Collect data and prepare relevant documentation.
7. Ensure appropriate archiving of all documents associated to laboratory activities.
8. Adhere, understand and apply EHS rules in place.
9. Mentor RAI, RAII and foreign visitors in their laboratory's activities and on project management.
10. Propose process improvement
11. Mainly act as method developer and/or analytical lead
12. As senior method developer,
- Collect information required for the analytical target profile from project manager, supervision, product owner.
- Propose new techniques and develop analytical method without assistance.
- Collect data from development and take decisions based on the obtained results, prepare support and present development status in technical review meeting.
- Advise supervision when facing issue and propose options to meet timelines or provide new timelines in case of troubleshooting
- Design complex study design and write protocols, reports and procedures autonomously as study director
- Participate to evaluation, validation or transfer of analytical method according to study protocol. Ensure all reagents, raw materials and equipment are available to run testing design, perform experiments, document activities in an appropriate way and advise supervisor in case of deviation or failed acceptance criteria.
- Process development/validation/transfer results and review it in a critical way, ensure deviations are documented correctly
- Conduct the investigation on failed acceptance criteria without assistance. Analyze data, propose hypothesis and document investigation accordingly
- Review reports to ensure data accuracy and completeness
- Write validation and method summaries dedicated to submission files without assistance
- Collect data to answer to authorities questions on analytical methods, write response in an clear and structured way autonomously.
- Support receiving site in the scope of method transfer by sharing experience from development and technical knowledge on the method
13. As senior analytical lead,
- Collect information related to product, specification, validations, timelines, release and stability sites. Analyze documents and identify gaps/risks in term of analytics (vs guideline, internal specifications, ) to build the Analytical Business Strategy for more complex and/or medium to large size projects.
- Identify requirement in terms of equipment and reference standards for sites impacted by the project
- Support technical lead on definition of commitments and plan analytical activities for the different sites to ensure these commitments will be met (development, evaluation, validation, documents issuance, waiver redaction, )
- Build the visual planning (Dashboard) and maintain it up to date
- Organize follow-up meetings with teams impacted by the ABS
- Participate actively to technical team meeting to give a status on analytical activities and ensure interactions with the different functions of the team (PMO, Mgt, RA, Sol DEV, Container, ).
- Anticipate and communicate in an appropriate way possible delay on timing due to limited resources or equipment availability, propose alternatives and challenge the appropriateness of activities.
- When required, contact external partners and ask for analytical activities quotations.
- Evaluate the number of resources required for each analytical activity on the different sites.
- Delegate activities to other team members when required (depending of the project size) and this with approval of supervision
- Take decision on project independently based on his previous experience and propose activities to reply pro-actively to potential questions from authorities
Qualifications:
Possess a strong technical knowledge on analytical techniques with previous experience on development, validations or investigation on analytical method.
Possess a previous experience in project management and understand the roles and interactions with other disciplines as formulation, regulatory affairs, process development, quality control, etc
Present a good knowledge of Baxter products, ICH guidelines and submission process
Able to identify and solve technical issues thanks to his/her critical mind and out of the box thinking.
Able to work in a team environment and demonstrate an inclusion attitude.
Takes ownership and leadership for getting the job done.
Eagerness to learn and is the motor of his knowledge development by prospecting for training
Strong communication skills and can write in a clear way
Can manage conflicts and influence other
Autonomous, organized and precise
Flexible to changes
Scientific honesty