Overview
Position Summary:
The Senior Analyst is a key member of the Quality Control (QC) department at STA Pharmaceuticals Switzerland. This role is responsible for executing protocols related to analytical method validation, verification, and transfer in compliance with regulatory standards (cGMP, ICH, FDA, EMA). In addition to supporting method lifecycle activities, the position includes testing of raw materials, intermediates, and finished products, particularly in support of new product introductions, stability and registration studies, process validation, and cleaning validation.
As a senior team member, the individual serves as a center of competence within QC, offering knowledge transfer and technical support to junior analysts and contributing to continuous improvement of laboratory operations in accordance with GMP standards.
Responsibilities
Key Responsibilities:
1. Design and perform feasibility test for method transfer, validation and verification-
2. Troubleshoot and optimize analytical methods (e.g., HPLC, GC, UV-Vis, KF, dissolution).
3. Prepare protocols and reports for method transfer, validation, and verification.
4. Execute analytical protocols, methods, and procedures in alignment with cGMP documentation requirements.
5. Write and review GMP documentation including test methods, SOPs
6. Perform analytical testing using techniques such as HPLC, GC, UV/VIS, IR, KF dissolution, TOC, titration, pH, conductivity, and weighing.
7. Review analytical data and ensure compliance with regulatory expectations and data integrity principles.
8. Support lab investigations, deviations, OOX results, and change controls within the applicable quality systems.
9. Act as a QC representative in cross-functional projects and support internal/external audits.
10. Contribute to the selection, qualification, and commissioning of new laboratory equipment.
11. Writes specific standard operations procedures (e.g. operation and maintenance of equipment).
12. Maintain supplier relationships and oversee maintenance and calibration activities.
13. Support procurement and inventory of laboratory consumables.
14. Provide mentorship, training, and support to other QC team members.
Qualifications
Required Qualifications:
15. Bachelor’s or Master’s degree in Analytical Chemistry, Pharmaceutical Sciences, or related field.
16. Minimum 4–6 years of hands-on experience in a GMP-regulated QC laboratory.
17. Strong experience in method validation and transfer per ICH guidelines.
18. Proven proficiency in a wide range of analytical techniques.
19. Solid understanding of GMP, data integrity, and regulatory requirements.
20. Excellent communication, technical writing, and organizational skills.
21. Familiarity with LIMS, Empower, and quality software tools.
22. Excellent team spirit.
23. Open-minded, adaptable, and solution-oriented, with a collaborative mindset.
24. Very good knowledge in English and French.
Preferred Skills and Experience:
25. Experience supporting new product introductions or method transfers.
26. Participation in audits as a subject matter expert.
27. Experience in project manager is a plus.