Quality Systems Specialist
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Job Location:
Monthly Salary:
Posted on:
8 hours ago
Vacancies:
1 Vacancy
Job Summary
Company overview:
TraceLinks software solutions and Opus Platform help the pharmaceutical industry digitize their supply chain and enable greater compliance visibility and decision making. It reduces disruption to the supply of medicines to patients who need them anywhere in the world.
Founded in 2009 with the simple mission of protecting patients today Tracelink has 8 offices over 800 employees and more than 1300 customers in over 60 countries around the world. Our expanding product suite continues to protect patients and now also enhances multi-enterprise collaboration through innovative new applications such as MINT.
Tracelink is recognized as an industry leader by Gartner and IDC and for having a great company culture by Comparably.
Position Overview
The Product Quality Specialist role within the Regulatory and Quality Compliance (RQC) department will work to ensure that TraceLinks life sciences applications and service offerings comply with applicable global regulations and standards (i.e. ISO 9001 FDA 21 CFR Part 11 EU Annex 11 FDA guidance documents GAMP5) and customer requirements. This position serves as embedded independent oversight within the Software Development Lifecycle (SDLC) process.
Responsibilities
- Review product test plan documents as per the requirements design in a timely manner per the SDLC.
- Review defined software release criteria and approve new software versions for release to customers.
- Primary RQC representative to participate in software deployments to customer environments as scheduled (includes night and weekend deployments).
- Verify Installation Qualification (IQ) for deployments following TraceLink procedures.
- Create review and approve IQ and Operational Qualification (OQ) Certificates for customers.
- Support risk management activities and improvements related to the SDLC.
- Serve as RQC department representative at various SDLC related meetings.
- Support the CAPA program for SDLC-related issues including performing root cause analysis (RCA) and working with departmental representatives to determine and track corrective and preventive actions to completion in a timely manner.
- Author RCA summary reports for customer distribution for applicable CAPAs.
- Perform and document internal tool assurance activities and work with other departments to evaluate tools based on TraceLink procedures.
- Review and approve validation documents for TraceLinks automated validation service offering.
- Ensure organizational compliance with applicable global regulations and standards TraceLink QMS processes and customer requirements.
- Ensure quality for SaaS products and service offerings is maintained.
- Identify and propose process improvements efficiencies or changes related to the SDLC or RQCs supporting activities.
- Support customer audits or requests for information. Support internal audits.
- Support ISO 9001 and 27001 audits.
- Contribute to quality metrics and key performance indicator reporting quality objectives and team initiatives.
Required Skills and Qualifications
- BS in engineering computer science information systems or other scientific discipline.
- 5 years performing software validation assurance and/or qualification activities within the pharmaceutical life sciences medical device or other related industry.
- Demonstrated knowledge of global regulations and standards related to software development validation and risk management for the Pharmaceutical Medical Device or Life Sciences industry (e.g. US FDA 21 CFR 11 EU Annex 11 ISO 9001 ISO 27001 FDA Computer Software Assurance CSA US FDA 21 CFR 820/211 GAMP5 ICH Q9 Q10).
- Ability to work independently and as a team member in fast-paced environment in an effective and flexible manner.
- Strong interpersonal skills to be able to build trust and relationships with cross-functional teams challenge constructively and collaborate and deliver results as a team.
- Strong written and verbal communication skills.
Preferred Skills and Qualifications
- Familiarity with cloud-based software qualification development requirements authoring or automated testing.
- Familiarity with Amazon Web Services (AWS) IaaS.
- Computer System Validation (CSV) and/or Computer Software Assurance (CSA) experience with the understanding of following Standard Operating Procedures independent reviews and documentation requirements.
- Vendor audit or Internal Audit experience.
Please see the Tracelink Privacy Policyfor more information on how Tracelink processes your personal information during the recruitment process and if applicable based on your location how you can exercise your privacy rights. If you have questions about this privacy notice or need to contact us in connection with your personal data including any requests to exercise your legal rights referred to at the end of this notice please contact .
Required Experience:
IC
Key Skills
- Quality Assurance
- FDA Regulations
- Data Collection
- Food Safety Experience
- ISO 9001
- Mobile Devices
- Root cause Analysis
- Quality Systems
- OSHA
- Food Processing
- Quality Management
- cGMP
About Company
TraceLink is the only network creation platform company that builds integrated business ecosystems with multienterprise applications - the true foundation for digitalization - delivering customer-centric agility and resiliency for end-to-end supply networks and leveraging the collecti ... View more
