QA Compliance Specialist
QA Compliance Specialist
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Job Description
Job Description Summary
The Compliance specialist is responsible to collaborate with relevant manager for maintaining and developing the quality systems strategy policies processes standards and procedures to ensure the site complies with regulatory and GMP compliance requirements as described by authorities and by Novartis/Adacap guidelines and quality manual.The function supports the manager to guarantee that global procedures are implemented in the sites quality systems and challenges the system for further improvement. The function supports in the sites inspection readiness and is a key contributor of the inspection management program.
Job Description
Major accountabilities:
- Collaborates to ensure that the sites quality system is maintained compliant to regulatory and GMP compliance requirements.
- Collaborates in the management of the sites quality systems documentation and reviews defines updates and approves (when agreed with the quality management) site specific quality systems documents.
- Provides oversight for the implementation of Quality Systems and Regulatory Compliance including management of Non conformances CAPAs Effectiveness Checks Change Controls Training Inspections and Audit readiness Technical complaints Risk Assessments and remediation Annual Product Quality review self-assessments KPIs and Quality Management
Review. - Support the manager in the design and oversight of strategic site quality system and works in collaboration with site functions to define written procedures including but not limited to monitor and control of the manufacturing environment training document control/record retention deviations/CAPA investigations and monitoring compliance with all requirements of good
manufacturing practice. - Support the quality management to develop and deliver a robust overall quality system strategy and ultimate plan resulting in a fully compliant quality system infrastructure with respect to procedures and processes.
- Provides oversight for audit and inspection management inspection strategies preparation interactions and responses.
- Support the quality team in the health authority inspection preparation and ensures key support during MOH and Novartis global audits.
- Develop Health Authority communications including written correspondence
responses to inspection observations presentations and verbal communication - Works with quality and compliance team to ensure robust quality systems are implemented and
sustained including deviation/CAPA Management: Ensures all deviations from established
procedures are appropriately documented and investigated to determine and fix root cause. - Support escalation of Quality/cGMP issues and deficiencies to the Site QA Head and support global escalation process if needed. Support associates within the Novartis network incase of Health Authority Notifications (s.a. FAR Rapid alert recalls)
Minimum Requirements:
- Education: Bachelors Degree in Pharmacy or MSc in Pharmaceutical Industry.
- 2 years of experience in a GxP (Bio)pharmaceutical or API manufacturing operations up of which 1 years of experience in a Quality Assurance role.
- Excellent communication skills
- Fluent English and Spanish written and spoken.
Why NovartisOur purpose is to reimagine medicine to improve and extend peoples lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here: and rewards: Read our handbook to learn about all the ways well help you thrive personally and professionally: to Diversity and Inclusion:
Novartis is committed to building an outstanding inclusive work environment and diverse teams representative of the patients and communities we serve.
Skills Desired
Continued Learning Dealing With Ambiguity Gmp Procedures Qa (Quality Assurance) Quality Control (Qc) Testing Quality Standards Self-Awareness Technological Expertise Technological IntelligenceRequired Experience:
Unclear Seniority
Employment Type
Full-Time
