Senior Specialist QA (Contingent worker)

Overview

This position will be working closely with the QA management to identify and handle process quality and cGMP compliance related issues, as well as to contribute to process improvement in his/her scope of activity.

This position will give support to partner departments for review /approval of documents including the batch record.

The Senior Specialist can act as the back-up of his peers.

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 Generic Master Batch Records (GMBR) for bulk or packaged commercial drug products and for New Product Introduction.
• Is responsible for the review "on the floor" (if applicable) of executed batch records and associated QA samples (API, raw materials,SDD, bulk, semi-finished and finished products).
• Handles deviations, Complaints, CAPA, and Change Control related to Couvet site and to ensure the execution and the follow up of escalation processes.
• Handles in cooperation with partners for GMP activities.
• Writes new, revises and makes recommendations for SOP and quality documents for Quality department and supported departments of Couvet manufacturing site.
• Responsible for Quality Oversight with follow-up on deviations, investigations, OOX, CAPA handling and Change Management. As a SME, this role supports or executes investigations, root cause analyses and CAPA definition as needed and appropriate.
• Participates as QA representative on site expansion projects.
• Handles qualification and validation documentation for QA review of relevant documents / reports (DQ, IQ, OQ, PQ, UAT, Cleaning Validation, Process Validation) and supports execution.
• Participates on project leadership teams for the development and integration of business applications including but not limited to LIMS, MES, SAP, OSI-PI. Provides clear communication to his manager on the overall compliance of the projects.
• Support QC/QA transfers of new products/methods to Couvet site.
• Supports the internal GMP-audits process, the follow-up and the implementation of the internal audit CAPAs.
• Handles in cooperation with partners for GxP activities, e.g., by participating in risk assessments, brainstorming related to quality issues.
• Provides support to the QA NPI - QA Validation and QC Team.
• Provides collaborative support and Quality oversight regarding computerized and automated systems validation requirements.
• Provides support and guidance to the QC department, identifies and handles QC and cGMP compliance related issues.
• Ensures successful Authorities inspections by participating in the preparation and the support in different roles (i.e., Backoffice, Subject Matter Expert, Scribe or Runner).
• Ensures that all regulations concerning product security and all established working methods are respected within the area of responsibility.

 

 Specific duties and responsibilities

• Handles review of recipes, routings, dynamic parameters of master batch record as QA duties and responsibilities.
• Change owner for Quality Operations
• Ensure customer relations related to quality topics
• Act as the back-up of the Senior Manager if required.

Qualifications

Experience / Education   

• Minimum 5 years of experience in Quality Assurance in a pharmaceutical company or other related industry.
• BSc/BA or MSc in Science or relevant discipline.
• Thorough understanding of cGMPs and Swiss, EU, and FDA regulatory requirements.

 

Knowledge / Skills / Abilities:

•  Intermediate knowledge of current Good Manufacturing Practices (cGMPs), Good Automated Manufacturing Practice (GAMP), Food and Drug Administration (FDA), and other regulatory requirements.
• Knowledge in the use of business, scientific and personal computer software and hardware, system security data collection hardware, operating systems and application software.
• Strong system and process insight: impact and consequences on compliance, operations and cross-functional areas.
• Good understanding of solid oral dosage form packaging and warehousing, or bulk and QC
• Excellent interpersonal collaborative, organizational and training skills.
• Excellent team player attitude.
• Ability to manage various projects in a stressful and a moving environment, create and work within internal timelines, solve problems, deliver on commitments and utilize interpersonal skills in a cross-functional team.
• Works independently, yet effectively in a team environment, makes proposals and facilitate decision when escalation is needed.
• Excellent written & oral communication skills in both French and English.
• Excellent investigational skills and QA problem solving skills.
• Ability to focus attention to details and to handle multiple tasks while working against pressures of deadlines.
• Sense of responsibility, reliability, flexibility, 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.