QMS Specialist I

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Office

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.

DESCRIPTION:At Thermo Fisher Scientific, you'll join a quality assurance team focused on ensuring consistent execution of quality standards and regulatory compliance. You'll play a vital role in enabling our customers to make breakthrough discoveries and innovations that make the world healthier, cleaner and safer. You'll ensure product quality, drive continuous improvement initiatives, and collaborate with cross-functional teams to maintain the highest standards of quality and compliance in a GMP environment.

Responsibilities

• Responsible for writing relevant procedures and reviewing all SOPs from other functional teams.
• Ensure QMS system (e.g. TrackWise, eDMS, SFLMS etc.) is configured and maintained to support GxP compliance. Authors SOPs / Work Instructions related to QMS.
• Maintain site change control system, develop effective change control evaluation methodology, oversee and coordinate the execution of site change control procedure, to ensure all changes which will potentially impact product quality are appropriate evaluated and effective controlled.
• Maintain site CAPA system, including but not limited to designing effective actions and effectiveness check methodology, ensure actions completed on time, and coordinate effectiveness check for actions.
• Manage corporate standards gap assessment at site level, ensure site practice compliant with regulatory requirements.
• Maintain document and record management system, develop department document control and cross function document champion team, oversee and coordinate the effective execution of site document management requirements. Ensure document execution compliant with site management requirements, guide and oversee supplier for record archival, ensure all C&Q executed records are archived.
• Maintain GMP training system, develop cross function training champion team, oversee and coordinate the effective execution of site training and personnel qualification.
• Develop annual training plan. Introduce, develop and improve site GMP training modules.
• Execute site self-inspection program, to ensure site practice compliant to cGMP and corporate policies, and work on continues improvement of site compliance.
• Coordinate and complete Inspection readiness activities to ensure site ready for both client and regulatory audits at all times.
• Participate in hosting client and regulatory audit, responsible for timely and effective execution of external audit commitments.
• Support site management review process, collect quality data, analyze compliance performance trend, be able to identify and manage the metrics, and responsible for continues improvement.
• Provide quality oversight on site supplier management program
• Maintain and track all QMS events to close within due dates without any overdue records.
• Maintain site data integrity system and oversight of effective implementation across the site.
• Execute any other related work assigned by company.

EHS

• Understand and ensure implementation of emergency procedures and safe systems of work.
• Ensure compliance with environment, health and safety rules, signage, and instructions at all times.
• Ensure prompt reporting and investigation of all accidents, near misses and breaches of rules.

Minimum Requirements/Qualifications

Education:

• Bachelor’s Degree in Life Sciences or Chemical/Biochemical engineering, Pharma related Scientific Area

Experience:

• 1 - 3 years of relevant Quality experience in pharmaceuticals preferred. Fresh graduate with relevant qualifications may also be considered.
• Experience in Quality Management System, Track Wise specifically an asset.
• Experience in biologics and aseptic training is an asset.
• Experience in site data integrity management is an asset.

Competencies:

• Knowledge in cGMP and Regulatory Compliance and GMP Quality Management System.
• Effective Systematical Thinking and Communication ability.
• Good Coordination and Collaboration.
• Effective execution and result driving.
• Good at problem solving and Quality Risk Management knowledge and tool.