Associate Specialist QA Operations

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Associate Specialist QA Operations, Val-de-TraversClient:

WuXi AppTec

Location:

Val-de-Travers

Job Category:

Other

Job Reference:

d3f237a3d1ad

Job Views:

8

Posted:

21.01.2025

Expiry Date:

07.03.2025

Job Description:

Overview

QA Operations Team is committed to actively support the Couvet site and other departments to ensure cGMP compliant processes and products.

This position is responsible for quality assurance (QA) involved primarily with the review of bulk or packaged commercial drug products, raw material batches if required, and maintaining working relationships with QA departments at contract facilities. The position will support on the floor QA activities (deviation, CAPA, OOS, change control, batch release, archiving, complaints) at the Couvet site, including work in 2*8 shift if required. As a member of the Quality Operations team, this position will be expected to be a reliable source of information and interpretation of quality and cGMP compliance requirements. Furthermore, the position holder is responsible for identifying and handling packaging, warehouse, or bulk/QC and cGMP compliance related issues. Additional tasks include quality metrics, risk assessments, as well as support for health authorities’ inspections and corporate audits.

This position will work closely with the QA Operations management to identify and handle process quality and cGMP compliance related issues, ensure lean release of finished/semi-finished products, bulk products, or raw materials for production, and contribute to process improvement in their scope of activity.

Responsibilities

The position holder is responsible and accountable for the tasks given below. The list of tasks is non-exhaustive; according to business needs, other tasks might be assigned to the position holder.

The position holder:

• Supports the design of Master Batch Records for bulk or packaged commercial drug products.
• Is responsible for the review “on the floor” (if applicable) of executed batch records and associated QA samples (API, raw materials, bulk, semi-finished and finished products).
• Ensures compilation and archiving of the documentation for compliance with GMP as appropriate.
• Handles deviations, complaints, and CAPA related to the Couvet site and ensures the execution/follow-up of escalation processes.
• Handles GMP activities in cooperation with partners.
• Writes new, revises, and makes recommendations for SOP and quality documents for the Quality department and supported departments of the Couvet manufacturing site.
• Handles qualification and validation documentation for QA review of relevant documents/reports (DQ, IQ, OQ, PQ, Cleaning Validation, Process Validation) and supports execution.
• Supports during Authorities inspections and internal audits, when requested.
• Represents QA within department and cross-functional project teams according to assignments.
• Participates in recommendations for continuous improvements in Quality systems as required.
• Contributes to regular reporting of quality process metrics.
• Ensures that all regulations concerning product security and all established working methods are respected within the area of responsibility.

Qualifications

Experience / Education

• BS in science or relevant discipline.
• At least 1-2 years of Quality Control and/or Quality Assurance experience in a pharmaceutical company or other related industry.

Knowledge / Skills / Abilities:

• Good understanding of cGMPs and Swiss, EU, and FDA regulatory requirements.
• Good understanding of Solid Oral Dosage from packaging and warehousing, or bulk and QC processes.
• Excellent interpersonal, collaborative, and organizational skills.
• Works independently, yet effectively in a team environment.
• Strong written & oral communication skills in both French and English.
• Very good investigational and QA problem-solving skills, has a keen eye for Quality, makes proposals, and facilitates decisions when escalation is needed.
• Ability to focus attention to detail and handle multiple tasks while working against pressures of deadlines.
• Sense of responsibility, reliability, team spirit, initiative, and service.
• Knowledge of most common office software.

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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