Company Description
MakroCare is an Expert Strategic Development and Commercialization Global Partner for the Pharmaceutical, Biotechnology and Medical Device industries. Our Experience, Programs and Processes bring a New Dimension to Development Strategy, Regulatory/Risk Planning & Management, Clinical Research, Medical/Scientific Support and Emerging Region Expansion.
MakroCare is Certified ISO 9001 (QMS), ISO 27001 (ISMS), ISO 20000 (ITSM), ISO 14155 (Medical Device Clinical Investigations)
Role Overview:
Responsible for the development, implementation, and effectiveness of quality strategies, programs and functions for all products and technical solutions to meet all corporate and regulatory objectives with respect to quality initiatives.
Summary: Plans, coordinates and directs activities concerned with DDi QMS, Quality manual, compliance-related activities (ICH, 21 CFR, GPDR etc), SOP management, and regulatory compliance of processes and products.
Plans and coordinates the quality management program designed to ensure quality development of products consistent with established standards.
Accountabilities:
- Interfaces with customers and vendors representing the company as Quality champion.
- Formulates and maintains quality assurance objectives complementary to corporate policies and goals.
- Designs and implements quality assurance training programs to key personnel in conjunction with managers.
- Prepares and maintains control plans and revises/audits processes, responds to customer's quality concerns.
- Manage client and regulatory authority audits
- Maintains companywide Quality Management System and ISO 9001, 27001 and ISO 14155 compliance. Oversee and own SOPs for an entire organization
- Author or Review validation documentation (plans, protocols, test suites, reports, etc.).
- Contributes to project discoveries, project kickoffs, review proposals and statements of work to ensure CSV standards are represented.
- Coordinates client-specific validation activities with practice leads.
- Enforce QA requirements for IT quality systems with potential GxP impact.
- Support GxP decisions/strategies during validation projects.
- Document applicable deviations and documentation anomalies for computer systems undergoing validation.
- Provides leadership throughout the lifecycle of a project, guiding the understanding of the validation process that the project team has through design, development, and implementation to ensure project requirements are met.
- Review requirements, traceability matrices, test suites and test executions.
- Travel involved. Other duties as assigned.
KRA spread:
- QMS and corporate Quality management: 60%
- Validation: 40%