As a key member of our team, you will play a vital role in maintaining the Good Manufacturing Practice (GMP) status of our Quality Control laboratory.
Key Responsibilities
* You will be responsible for managing analytical transfer projects involving various stakeholders, including customers and internal departments.
* You will be responsible for introducing new methods in QC:
o Evaluate method clients and identify blocking points.
o Perform or support feasibility experimental work as needed.
o Manage transfer/verification/validation protocols and reports.
o Implement methods and manage methods/specification documentation.
o Implement cleaning methods and participate in cleaning validation.
* You will perform analytical testing according to raw material and product release specifications.
* You will review analytical data.
* You will support the introduction of new technologies:
o Work cross-functionally with QC support, commercial team, QA, IT, and other departments to select, purchase, and qualify new technologies for the QC laboratory.
o Perform feasibility experimental work as needed.
* You will use scientific and technical expertise to investigate and resolve technical issues in the laboratory.
o Own deviations, lead or support laboratory investigations.
o Write or review investigative testing plans or retest plans prior to execution.
o Define corrective and preventive actions (CAPA).
* You will maintain the GMP status of the laboratory and analytical methods.
* You will evaluate the impact of compendial changes on applicable QC procedures and open change controls as required.
* You will communicate effectively with management regarding complex issues.
* You will conduct effective training of QC personnel (QC analysts, QC scientists).
* You will actively participate in inspections by health authorities and corresponding preparation.
* You will author and update documents, such as procedures, work instructions, protocols, reports, and other QC documents.
* You will review and approve documents issued by the QC team.
* You will represent the QC department in transversal projects.
* You will ensure all Environmental Health and Safety (EHS) requirements are met in the laboratory: Respect EHS procedures and rules.
Qualifications and Skills
* A Master's or PhD degree in Life Sciences, Chemistry, Pharmacy, or equivalent.
* 5 years of work experience in a GMP environment (pharmaceutical industry).
Key Skills and Abilities
* Advanced knowledge and interpretation of cGMP and Pharmacopeia requirements.
* Thorough knowledge of quality systems and deviations handling.
* Takes a structured and analytical approach to problem-solving.
* Able to present topics as a Subject Matter Expert to internal and external audiences and at regulatory inspections and audits.
* Excellent scientific knowledge and hands-on experience of chromatography techniques (HPLC, UPLC, GC), dissolution, UV, and IR techniques.
* Experience in analytical testing according to Ph. Eur., JP, and USP requirements.
* Advanced knowledge of analytical method transfers and analytical method validation/verification.
* Advanced GMP documentation skills and technical writing skills (procedures, protocols, plans, and reports).
* Experience in laboratory equipment qualification and software qualification.
* Advanced knowledge of Data Integrity principles and experience of audit trail review requirements.
* Good knowledge of and ability to quickly familiarize themselves with new software and computerized systems.
* General computer literacy, including MS Office (Word, Excel, PowerPoint, Outlook, Visio).
* Effective verbal communication skills and ability to interact with different levels of the organization.
* Ability to work collaboratively and cross-functionally in project teams.