QA Specialist Post-Approval

JOB DESCRIPTION

Work Schedule

Environmental Conditions

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

Fisher Clinical Services GmbH is a subsidiary of Thermo Fisher Scientific Inc. and is a market leader in Clinical Supply Chain Management Services and Clinical Supplies for patients worldwide.

Quality Assurance Specialist Post-Approval

Description:

The Quality Assurance Specialist, as a member of the QA Post-Approval team, is responsible for completing quality assurance activities effectively and on time. This includes the quality review and approval of executed batch records, creation of Certificates of Packaging/Manufacturing and review of supporting documentation according to customer and regulatory requirements, including Good Clinical Practice (GCP) and Good Manufacturing Practice (GMP) guidelines, and Fisher Clinical Services Standard Operating Procedures (SOPs).

The role requires an in-depth understanding of clinical trial supplies and the services that Fisher Clinical Services GmbH (FCS) is able to provide according to FCS quality standards and timelines. After appropriate training, the post holder is able to complete the tasks described under Responsibilities. Different tasks may have different training requirements and the post holder must be appropriately qualified.

Responsibilities:

• Review executed batch records (EBRs) and create Certificates of Packaging/Manufacturing in accordance with customer, regulatory, GMP/GCP and FCS requirements
• Coordinate and communicate the scheduling, prioritization and completion of documentation reviews and approvals and provide relevant information to support project planning
• Liaise with Project Management and other relevant functions to ensure documentation meets customer and regulatory requirements
• Support GMP document archival activities, as required.
• Participate in client meetings, audits and inspections as required, supporting QA Post-Approval and EBR-related topics.
• Support investigations, deviations, CAPAs and other quality events within the QA Post-Approval area, including applicable TrackWise activities
• Identify, document and escalate quality issues and support the analysis of quality and operational metrics
• Provide support to the wider Quality department and other quality-related activities, as applicable
• Identify and support improvement opportunities to optimize QA Post-Approval processes, documentation Right First Time (RFT) performance and daily operations.
• Support internal, external and cross-functional projects in the QA Post-Approval area, including continuous improvement, harmonization, digitalization, compliance and regulatory initiatives.
• Create, review and revise Standard Operating Procedures (SOPs), Work Instructions (WIs) and other controlled documents within the QA Post-Approval area
• Train and support new team members and provide QA Post-Approval process training to other FCS departments, as required
• Maintain accurate records for all work activities

Requirements:

• Experience or degree in the pharmaceutical industry, quality control/quality assurance, medication handling, scientific field or equivalent
• GxP training or experience
• Demonstrated ability to perform detail-oriented tasks
• Bachelor’s degree in science or equivalent or GxP training or previous experience in the pharmaceutical industry, quality, medication handling or scientific role
• Excellent communication and organizational skills
• High level of accuracy and efficiency
• Ability to express detail in simple terminology, both written and verbal
• Command of English and German at professional level

This job description does not describe all the duties, tasks and responsibilities which need to be performed in the Function. Any other job related instructions, duties, tasks or responsibilities which are requested by the team leader or manager are required to follow.