Quality Control Senior Scientist

Job title:

Quality Control Senior Scientist

Company

WuXi AppTec

Job description

Overview:The Senior Scientist is part of the the Quality Control (QC) department of STA Pharmaceuticals Switzerland. The Team is responsible for introducing new raw materials, drug substance (API), and drug product (Bulk) as well as new technologies at the site. The Senior Scientist provides technical and scientific expertise to support transfer/verification/validation of new methods and investigation and troubleshooting of analytical issues (commercial or not). Additional duties includes participating to registration stability studies, participating to supplier qualification & supplier Audit, participating to cleaning validation and validation processes, and leading QC risk assessments.The Senior Scientist assists other technical support team members with questions and technical issues and acts as a point of contact in absence of the Manager. He/she plays an expert role and shares know-how with colleagues regarding methods, deviation, CAPA, Change control and QC processes. As a Senior QC Team Member, this position acts as a center of competences reflecting experience, transferring knowledge and support other team members in all aspects of their daily work.This position is located at STA Pharmaceuticals Switzerland site in Couvet. Responsibilities:A. Is responsible for introducing new methods (Raw Materials, APIs and Drug products)

• Evaluates method clients and identify blocking points
• Performs or support feasibility experimental work as needed
• Manages of the transfer/verification/validation protocols and reports
• Implements methods
• Manages the methods/specification documentation
• Implements cleaning methods and participates to cleaning validation

B. Is responsible for introducing new technologies:

• Works cross-functionally with QC support, the commercial team, QA, IT and other departments to select, purchase and qualify new technologies for the QC laboratory
• Performs feasibility experimental work as needed

C. Uses scientific and technical expertise to investigate and resolve technical issues in the laboratory (for all that needs scientifical and technical expertise when appropriate (QC complaints included)).

• Owns deviations, leads or supports laboratory investigations
• Can approve laboratory investigation checklists
• Provides guidance for confirmatory testing
• Writes or reviews investigative testing plans or retest plans prior to execution
• Defines corrective and preventive actions (CAPA)
• Can approve laboratory investigations and deviations as SME/Area Manager

D. Represents AS&T in project teams

• Represents AS&T in cross-functional project teams, interacting with Project Management Office, Manufacturing, QC Technical Support, QC commercial
• Leads or supports risk assessments, owns change controls
• Manages method transfer plans. Performs or supports feasibility experimental work as needed. Manages or support method transfer, method verification and method validation activities.

E. Maintains the GMP status of the laboratory and analytical methods.

• Performs all activities in compliance to cGMP requirements as well as to EHS rules and safe work practices per applicable procedures.
• Evaluates impact of compendial changes on applicable QC procedures and opens change controls as required.
• Performs other tasks as assigned

F. Acts as a Center of Competences and acts as a delegate of AS&T Manager

• Provides technical guidance, training and support to peers.
• Review and approve all documents generated by other team members
• Is a central point of contact in manager’s absence
• Communicates effectively with management regarding more complex issues.
• Assist with capacity forecasts and allocation of resources
• Conduct effective training of QC personal (QC analysts, QC scientists)
• Actively participates in inspections by health authorities and corresponding preparation
• Performs other tasks as assigned.

G. Electronic Document Management System

• Authors and updates documents, such as procedures, work instructions, protocols, reports and other QC documents
• Reviews and approves documents issued by AS&T team or others from the QC team

Qualifications:Experience / Education

• Bachelor’s degree in Life Sciences, Chemistry, Pharmacy or equivalent
• 10 years of work experience in a GMP environment (pharmaceutical industry)

Knowledge / Skills / Abilities:

• Advanced knowledge and interpretation of cGMP and Pharmacopeia requirements
• Thorough knowledge of quality systems as well as deviations and investigations handling.
• Takes a structured and analytical approach to problem solving. Is familiar with problem-solving and investigation tools and methodologies
• Able to present topics as Subject Matter Expert to internal audience, external audience and at regulatory inspections and audits.
• Excellent scientific knowledge and hands-on experience of chromatography

techniques (HPLC, UPLC, GC), dissolution, UVNIS and IR techniques. * Experience of 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, experience of audit trail review requirements.
• Good knowledge and/or ability to familiarize themselves quickly with new software and computerized systems (specific instrument software, Empower, LIMS).
• General computer literacy including MS Office (Word, Excel, PowerPoint, Outlook, Visio)
• Effective verbal communication skills, ability to interact with different levels of the organization: manager, supervisor, peers, lab analysts, and other departments
• Ability to work collaboratively and cross-functionally in project teams.
• Fluent in English or French and professional command of the second language (written and verbal)

An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disabilityThis job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.

Expected salary

Location

Couvet, Neuchâtel

Job date

Sun, 03 Nov 2024 04:40:16 GMT

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