Associate Specialist QA Operations

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 ) Couvet site included work in 2*8 shift if required.

As a member of Quality Operations team, this position will be expected to be reliable source of information and interpretation of quality and cGMP compliance requirements.

Furthermore, the position holder is responsible to identify and handle packaging, warehouse, or bulk / QC and cGMP compliance related issues.

Additional tasks are quality metrics, risk assessments, as well as the support of health authorities’ inspections and corporate audits.

This position will be working closely with the QA Operations management to identify and handle process quality and cGMP compliance related issues, ensure lean release of finished / semi-finished product, bulk product, or raw materials for production, as well as to contribute to process improvement in his / her 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).
• Ensure compilation and archiving of the documentation for compliance to GMP as appropriate.
• Handles deviations, complaints and CAPA related to Couvet site and to ensure the execution / follow up of escalation processes.
• Handles in cooperation with partners GMP activities.
• Writes new, revises and makes recommendations for SOP and quality documents for Quality department and supported departments of 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.
• Support during Authorities inspections and internal audits, when requested.
• Represents QA within department and cross functional project teams according to assignments.
• Participate to recommendations for continuous improvements in Quality systems as required.
• Contributes of regular reporting of quality processes 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 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 facilitate decision when escalation is needed.
• Ability to focus attention to details and to handle multiple tasks while working against pressures of deadlines.
• Collaborative, organisational
• 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.