Dear Associate,
Please check the below requirement and advise us the right consultant's along with Rate, Availability, Contact Details, Current Location & Visa Status.
It's an immediate requirement please sent me the suitable resumes ASAP.
Please check the below requirement and advise us the right consultant's along with Rate, Availability, Contact Details, Current Location & Visa Status.
It's an immediate requirement please sent me the suitable resumes ASAP.
Please make sure the candidate has all the required skills & Send me the resumes on Email: davis.clayton@panzersolutions.com
Position: QA Manager - Pharmaceutical
Location: Gaithersburg MD
Duration: 6+ Months Contract
Start Date: ASAP
Job Responsibilities:
Responsible for design and implementation of End-to-end migration process for P2V, V2V and forklift transfers to new UCS (Cisco/NetApp/VmWare) cloud platform.
Successfully migrated over 300 applications, about one-third of which were validated applications.
Coordinated migration, test and operations/support hand-off. Responsible for new IS PDM SDLC implementation as well as review and approval of all project deliverables.
Designed and implemented new Qualification Standard procedure. Led project for Data Center Qualification for 2 major data centers, including as-built computer rooms, platforms, network components and tools used for business as usual operations.
Responsible for compliance and implementation of quality program for software deployed to communicate with implanted pacemakers.
Integrated proprietary SDLC into existing Medical Device Quality program which included design transfer, Safety, Security (ISO 27001), software validation and review and approval of deliverables.
Managed and provided regulatory compliance guidance to all members of the project team.
Reviewed validation and qualification records for compliance to 21 CFR Part 11, as well as for compliance to corporate policies, processes, SOPs, standards, and guidelines.
Managed and provided regulatory compliance guidance towards the development/review of validation/qualification records, including Risk Assessments (RAs), Quality Assurance Plans (QAPs), Data Migration Plans (DMPs) Requirement Specifications (RSs), Mapping Requirement Specifications (MRSs), Design Specifications (DSs), Configuration Specifications (CSs), Impact Assessments (IAs), Test Plans (TPs), Installation/Operational/Performance Qualification (IQ/OQ/PQ) Test Scripts, Traceability Matrices (TMs), Data Migration Summary Reports (DMSRs), Quality Assurance Summary Reports (QASRs), and Release Authorization Notices (RANs).
Trained Project Managers, SMEs/Technical Reviewers, Developers, QA Analysts/Testers, and Quality Reviewers in all phases of Computer Systems Validation (CSV), 21 CFR Part 11, and SDLC compliance.
Location: Gaithersburg MD
Duration: 6+ Months Contract
Start Date: ASAP
Job Responsibilities:
Responsible for design and implementation of End-to-end migration process for P2V, V2V and forklift transfers to new UCS (Cisco/NetApp/VmWare) cloud platform.
Successfully migrated over 300 applications, about one-third of which were validated applications.
Coordinated migration, test and operations/support hand-off. Responsible for new IS PDM SDLC implementation as well as review and approval of all project deliverables.
Designed and implemented new Qualification Standard procedure. Led project for Data Center Qualification for 2 major data centers, including as-built computer rooms, platforms, network components and tools used for business as usual operations.
Responsible for compliance and implementation of quality program for software deployed to communicate with implanted pacemakers.
Integrated proprietary SDLC into existing Medical Device Quality program which included design transfer, Safety, Security (ISO 27001), software validation and review and approval of deliverables.
Managed and provided regulatory compliance guidance to all members of the project team.
Reviewed validation and qualification records for compliance to 21 CFR Part 11, as well as for compliance to corporate policies, processes, SOPs, standards, and guidelines.
Managed and provided regulatory compliance guidance towards the development/review of validation/qualification records, including Risk Assessments (RAs), Quality Assurance Plans (QAPs), Data Migration Plans (DMPs) Requirement Specifications (RSs), Mapping Requirement Specifications (MRSs), Design Specifications (DSs), Configuration Specifications (CSs), Impact Assessments (IAs), Test Plans (TPs), Installation/Operational/Performance Qualification (IQ/OQ/PQ) Test Scripts, Traceability Matrices (TMs), Data Migration Summary Reports (DMSRs), Quality Assurance Summary Reports (QASRs), and Release Authorization Notices (RANs).
Trained Project Managers, SMEs/Technical Reviewers, Developers, QA Analysts/Testers, and Quality Reviewers in all phases of Computer Systems Validation (CSV), 21 CFR Part 11, and SDLC compliance.
Required Skills:
MUST have Pharma experience (experience in a heavily regulated environment).
the candidate needs to have infrastructure expertise in a regulated environment thorough understanding of qualification/validation principles and practices.
Does not need to be a GXP expert, but demonstrated knowledge of IQ's, OQ's and qualification (platforms, network, backups, etc.).
- Infrastructure experience, including server builds,
- Planning, designing, and evaluating various components of network.
- Evaluate and recommend new technologies to enhance current capabilities
- Capable of creating and updating system documentation
- Very important that the candidate(s) has Compliance experience and experience with validated environments.
=======================================================================================
Thanks & Regards
Davis Clayton | Sr Recruiter
Panzer Solutions LLC *45 Stuart Ave, K Unit *Norwalk CT 06850 USA
Voice : 203-652-1444 Ext: 120 *Fax : 203-286-1457
Email: davis.clayton@panzersolutions.com
-- MUST have Pharma experience (experience in a heavily regulated environment).
the candidate needs to have infrastructure expertise in a regulated environment thorough understanding of qualification/validation principles and practices.
Does not need to be a GXP expert, but demonstrated knowledge of IQ's, OQ's and qualification (platforms, network, backups, etc.).
- Infrastructure experience, including server builds,
- Planning, designing, and evaluating various components of network.
- Evaluate and recommend new technologies to enhance current capabilities
- Capable of creating and updating system documentation
- Very important that the candidate(s) has Compliance experience and experience with validated environments.
=======================================================================================
Thanks & Regards
Davis Clayton | Sr Recruiter
Panzer Solutions LLC *45 Stuart Ave, K Unit *Norwalk CT 06850 USA
Voice : 203-652-1444 Ext: 120 *Fax : 203-286-1457
Email: davis.clayton@panzersolutions.com
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