Website Macpower Digital Assets Edge Private Limited
Macpower Digital Assets Edge Private Limited
Company : Macpower Digital Assets Edge Private Limited
Responsibilities:
- Lead Computer Software Validation (CSV) project planning activities, including the creation and updates of User Requirements Specifications (URS), Software Design Specifications (SDS), and Requirements Traceability Matrices (RTM).
- Develop, review, and approve software validation documentation.
- Create and execute qualification protocols, document reports, and review and approve software test scripts and code reviews.
- Evaluate and approve internal and vendor software packages and test documentation.
- Prioritize and manage all assigned projects within the software validation department.
- Implement and support policies, procedures, and processes related to CSV, Software Development Life Cycle (SDLC), and software validation for computerized systems.
- Serve as the Software Quality Engineering (SQE) representative in the Change Control Board (CCB) to facilitate change validation.
- Lead Installation Qualification (IQ) activities for manufacturing lines.
- Drive CSV improvement initiatives within the manufacturing environment.
- Promote cross-functional collaboration across different teams, sites, and operating companies in the area of CSV.
- Identify and resolve obstacles that impact business needs.
- Work closely with Franchise Quality to implement and sustain Quality System initiatives at the site level.
- Support compliance efforts by ensuring audit readiness and participating in internal and external audits related to CSV.
- Act as the Subject Matter Expert (SME) for CSV, leading investigations, responses, and remediation of site-specific CSV audit findings.
Qualifications:
- Strong working knowledge of FDA and European medical device regulations (QSR and ISO).
- Expertise in software validation requirements for both medical device production and Quality System software.
- Proficiency in GAMP5 and SDLC methodologies.
- In-depth understanding of regulations for electronic records, electronic signatures, and data integrity.
- Experience in change management with strong technical writing skills.
- Hands-on experience with SCADA and/or Manufacturing Execution Systems (MES), with a background in manufacturing/operations.
- Medical device process validation experience (preferred).
- Experience in Quality Auditing and notified body inspections (preferred).
- Background in Quality Systems process development, support, integration, or enhancement (preferred).
- Experience in training or coaching others (preferred).
- Certification as a Software Quality Engineer (CSQE) or Quality Engineer (CQE) (preferred).
Must-Have Skills:
- Minimum of 4 years of experience in a regulated environment.
- 2-4 years of experience in medical device regulations.
- Strong knowledge of FDA and European medical device regulations (QSR and ISO).
- Expertise in software validation for medical device production and Quality System applications.
- Working knowledge of GAMP5 and SDLC.
- Understanding of electronic records, electronic signatures, and data integrity regulations.
- Experience with change management and technical writing.
- Hands-on experience with SCADA and/or MES in a manufacturing/operations setting.