Student Veterans of America Jobs

Overview

Quality Control is responsible to support the entire Couvet site to ensure that each analytical and microbiological testing is performed in compliance with the site’s Quality Management Systems (QMS), the cGMP, the applicable laws, regulations, and standards, and in compliance with the Product’s Dossier managed by the Customer.

The position holder is responsible, within the frame of AS&T, of any testing-related topic to ensure the execution of new technology/product method transfer and/or validation, the creation of adequate testing methods and specifications and their associated training strategy and material, and, for the commercial testing, of owning the analytical method and of leading the investigation of any significant laboratory deviation.

As a member of the Quality Control Leadership Team (QCLT), the position holder is collaborating with the other members of the QCLT to ensure that the testing methods, processes, and techniques are maintained and improved and that any cGMP/GLP compliance issues is duly addressed in a timely manner.

Responsibilities

• Builds and leads a team assuring that adequate staff, organization, equipment and facilities are available to complete the assigned tasks.

• Assigns tasks to direct reports in accordance with their responsibilities and capabilities. Ensures continuous professional development and guidance to direct reports.

• Assigns tasks to direct reports to ensure :

• Compliance of issued and executed protocol with applicable standards and Customer’s expectations,

• sampling of raw materials in collaboration with warehouse personnel is done according to applicable procedure which are continuously improved.

• definition of and adherence to the training strategy related to sampling and testing for the new product introduction.

• Responsible for resolution of analytical and sampling processes and protocol deviations related to new product, assuring effective root cause identification and corrective/preventive actions to of any deficiencies identified during new product method transfer and audits (internal, health authority, customer), and provide, if needed, support to resolution of deficiencies occurring during manufacturing, utilities production, batch record reviews… of commercial products.

• Ensures compliance to the policy of security at work and to laws concerning health and security of the workers within the area of responsibility

• Works closely with EHS to evaluate hazards and perform risk analysis

• Promotes safe practices and behaviors, verify that EHS rules are implemented and followed

• Support QC Director in definition and follow-up of:

• work force planning

• equipment and technology acquisition and improvement,

• budget,

• KPI

• QC representation in the weekly planning meetings of the New Product Introduction team

Qualifications

Experience / Education

• At least 5 years of experience in Quality Control in a pharmaceutical company or other related industry.

• Bachelor’s degree in Chemistry, Biochemistry, Microbiology, Pharmacy or related science.

Knowledge / Skills / Abilities:

• Thorough understanding of cGMPs, GLP, and EU, Swiss, and FDA regulatory requirements.

• Solid understanding of Oral Solid Dosage form manufacturing, packaging, warehousing processes and associated analytical and microbiological testing, method transfer/validation, analytical techniques (HPLC, UPLC, UV/VIS, IR, dissolution…) and overall laboratory workflows.

• Strategic thinking, business acumen, holistic approach, leading vision, innovation management, and negotiation. Ability to transfer strategies to tactical execution.

• Excellent interpersonal, collaborative and organizational skills.

• Strong communication skills. Ability to communicate effectively to management, functional groups, broader organization, and executives.

• High credibility and reliability.

• Excellent investigational and problem solving skills.

• Ability to interpret complex situations with degree of independence and to articulate recommendations for resolution.

• Subject matter expert of Quality Control activities in the pharmaceutical industry

• Drives continuous improvement.

• Knowledge of most common office software and of IT-principles.

• Capability to evaluate, investigate and solve problems related to new product introduction into the laboratory.

Leadership Activities: (only for people manager roles)

• Responsible for supervision/training of Operators (Junior, Senior, Lead) – previous supervisory experience not required, but is a plus.

• Must be able to work unsupervised, and along with operators/engineers.

• Must be able to organize and lead training sessions on new equipment or procedures.

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 disability

This 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.

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Job Locations CH-NE-2108 Couvet

Job ID 2024-12547