Overview
Job Summary:
QA Validation & QC 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 and approval of documentation related to projects and Site extension, mainly from Validation, Quality Control, Manufacturing, Maintenance, Metrology, New Products Introduction, IT departments.
As a team member, this position pro-actively collaborates to strategy definition and risk-based evaluation, to ensure Quality by design and cGMP compliance for Manufacturing /QC projects and systems implementation, upgrade, or transfer.
The Specialist QA Validation & QC is responsible for Quality oversight of computerized and automated systems according to current guidelines, global and local procedures, and regulations. The Specialist QA Validation & QC is also responsible for supporting the enforcement of Data Integrity principles and rules applied to computerized and automated systems at Couvet site.
The Specialist QA Validation & QC can be the QA representative for site extension projects.
The Specialist, QA Validation & QC can be assigned special tasks in cross-functional projects like New Products Introduction and launches.
As a key member of the Quality 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 manufacturing/QC and cGMP compliance related issues. Additional tasks are risk assessments as well as the support of health authorities’ inspections and corporate audits.
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.
The Specialist QA Validation & QC can act as the back-up of his peers.
Essential Job Functions:
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.
* Responsible for Quality Oversight with follow up on deviations, investigations, OOS, CAPA handling and Change Management. As a SME, this role supports or executes investigations, root cause analyses and CAPA definition as needed and appropriate.
* Provides expertise for Quality control topics, i.e OOS, OOT, OOE, method validation/transfer and pharmacopeial surveillance. On time closure of QC relevant events to conform with site planning requirements.
* Responsible for reviewing and approving IT Periodic Reviews and Validation Periodic Reviews related to computerized and automated systems as well as data integrity events.
* Participates actively 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.
* Responsible for reviewing and approving data integrity assessments of new and existing systems including, but not limited to, manufacturing and laboratory systems to ensure compliance with regulatory requirements.
* Support QC/QA transfers of new products/methods to Couvet site.
* Writes new, revises, and makes recommendations for SOP and quality documents for Quality department and supported departments of Couvet manufacturing site.
* Supports the design of Generic Master Batch Records (GMBR) for bulk or packaged commercial drug products.
* Handles in cooperation with partners for GxP activities, g., by participating in risk assessments, brainstorming related to quality issues.
* Provides support to the QA Operations commercial Team.
* Provides collaborative support and Quality oversight regarding computerized and automated systems validation requirements.
* Provides support and guidance to other departments and functions for Data Integrity topics.
* 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).
Job Requirements:
Experience / Education
* Minimum 3 years of experience in Quality Control and/or Quality Assurance in a pharmaceutical company or other related industry, preferably with related computerized systems validation and project management experience.
* 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.
* Intermediate knowledge in Health Authority regulations and guidance’s related to data integrity, data management, and Part 11 / Annex 11 compliance.
* 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.
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