On behalf of our client, a growing company based in Neuchâtel, we are currently looking for a
QC Senior Specialist, New Raw Material Introduction
Vos tâches
Position Summary | The QC Senior Specialist, New Raw Material Introduction is an active member of the New Product Introduction team in the Quality Control department at BMS Boudry.
This team is accountable for introducing new products into QC Laboratory as part of the technical transfer of new products at the Boudry site. The QC Senior Specialist, New Raw Material Introduction is responsible for introducing new materials into QC Laboratory. This individual plays a critical role in leading method development and verification/validation related to raw materials as well as establishing incoming testing specification. This position is working cross-functionally to support these activities and assess trial materials. Besides, the QC Senior Specialist, New Raw Material Introduction is supporting activities related to the Pharmacopeial compendial review, evaluates impact of compendial changes on applicable QC procedures and handles associated change controls. The position is reporting to the Senior Manager QC NPI. |
Votre profil
Duties/Responsibilities | Introduce new methods for raw materials into QC Laboratory:
· Represent QC in cross-functional project teams supporting New Product Introductions, Material Qualification and Material Risk Assessment processes for excipients; · Lead and support method transfer, method verification and method validation activities, both internally and externally with contract testing laboratories; · Write analytical methods, verification/validation protocols and reports, specifications, operating procedures; · Establish incoming testing specification for the release of raw materials and document rational for the establishment of testing; · Support with new equipment installation related activities; · Ensure training of QC personal on new incoming testing methods and procedures; · Support feasibility experimental work, as needed.
Perform trial material assessment: · Work collaboratively with QC Incoming Material, QC Commercial Drug Product and other cross-functional teams on testing requirements and sampling plans; · Coordinate testing of Trial materials; · Participate in cross-functional teams meeting and provide trial material assessment QC progress.
Assist management with scheduling testing and setting priorities of self and others: · Act as a project leader to ensure work is performed according to schedule; · Assist with allocation of resources, such as instrumentation and analyst availability; · Assist analysts with questions and troubleshooting; · Communicate effectively with management regarding complex issues; · Point of contact for raw materials matters in the absence of the Senior Manager.
Maintain the GMP status of QC incoming testing operations and promote continuous improvement: · Evaluate impact of compendial changes on applicable QC procedures and handles change controls, as required; · Own or support change controls related to incoming testing methods changes; · Identify and lead continuous improvement initiatives related to QC incoming activities.
Assists with review, verification, and approval of data: · Serve as technical reviewer of appropriate departmental procedures; · Review and approve documentation as required by laboratory procedures; · Perform peer review as needed; · Perform verification of software templates and custom fields as required.
Promotes safe practices and behaviors: · Report immediately incidents to Environmental, Health and Safety department ; participate in investigations and identify measures to prevent similar accidents in the future; · Demonstrate Bristol Myers Squibb values.
Perform other tasks as assigned and project work. |
Qualifications | · CFC as Laboratory Technician or BS degree in Science, Chemistry, or equivalent.
· Minimum 5 years of work experience in a GMP environment or regulated industry. · Advanced understanding of pharmaceutical regulatory requirements (cGMPs, JP, JPE, USP and Ph. Eur) and their impact to incoming material operations. · Advanced understanding of technical capability of instrumentation, software and techniques used in Incoming testing. · Experience in analytical method transfers and analytical method validation/verification. · Experience of analytical testing according to Ph. Eur., JP and USP requirements is a plus. · Good scientific knowledge of chromatography techniques (HPLC, UPLC, GC) and wet chemistry techniques. · General computer literacy including MS Office (Word, Excel, PowerPoint, Outlook, Visio). · Good knowledge of Data Integrity principles. · Effective verbal communication skills, ability to interact with different levels of the organization and other departments. · Effective technical writing skills, experience writing of GMP documents (procedures, protocols, plans and reports) as well as deviations and laboratory investigations. · Professional command of French and English, verbal and written. · Proven time management skills and a strong attention to detail. · Proven analytical and problem-solving skills. · Ability to work independently and compliantly.
Travel : This position does not require to travel (except for training purposes). |