VP and Mechanical roles are still open!!!
Project Manager (100% onsite )
Location: La Verne, CA
Client: Pharma
Duration: 12 months
Rate: $85hr W2 or $95hr c2c/1099
Okay with H1
Should know GxP, Validation and possibly MES
GxP Documentation is must
Pharma/ Biotech/ Life Sciences/ Medical Device/ Healthcare or Manufacturing experience is a must ( Okay with either industry )
Responsibility:
- This position is responsible for leading and performing activities in support of creating and maintaining GxP (GMP, GCP, and GLP) quality and compliance environment for SAP S/4 HANA. This position is also responsible for monitoring Computer System validation (CSV) as well as compliance with GxP regulations and 21 CFR Part 11.
- Leads the effort to manage, and/or maintains validation of SAP S/4 HANA system.
- Perform GxP and 21 CFR part 11 assessments and develop validation plan.
- Develop functional risk strategy and perform functional risk assessment.
- Review user business process documents and user requirements specification.
- Review functional, technical and configuration design documents.
- Prepare and/or review Configuration Qualification (CQ), Data Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ) and performance Qualification (PQ) protocols.
- Review the test scripts for the requirements and test scenario coverage.
- Lead overall protocol executions, log and track defects.
- Review the executed test reports for the proper documentation of test results and evidence.
- Review the defects for proper documentation per the checklist.
- Prepare and maintain the traceability matrix to ensure all the requirements are covered in design documents and tested.
- Prepare and approve qualification summary report.
- Participates in Corrective and Preventive Action (CAPA), Maintains quality metrics.
- Maintain overall project and issue tracker and report routinely.
- Support release management activities by reviewing and ensuring the pre-requisites are completed prior to the release.
- Review Quality System support documentation including Standard Operating Procedures (SOP), Work Instructions (WI) and training materials.
- Maintain day to day activities status tracker and report routinely.
- Lead the team of validation engineers located in different time zones.
Skills:
- Excellent communication (oral and written) and attention to detail.
- 8+ years in Computer System Validation in Life Science domain with minimum 3+ years of experience in managing large global SAP validation projects.
- Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude.
- Excellent knowledge of GxP regulations, FDA and EMEA (European Medicines Evaluation Agency ) guidelines including 21 CFR Part 11.
- Excellent knowledge of computer system validation and GAMP -5 standards.
Position: Sr. Validation Engineer (CSV) with decommissioning experience – 100% Onsite
Location: La Verne, CA
Client: Pharma
Duration: 12 months
Rate: $65hr W2 or $73hr c2c/1099
H1's accepted
Looking for profiles having around 10-12 years of overall experience
Responsibilities:
Creates Computer System Validation (CSV) deliverables (Validation Plan, Requirements Specifications, Protocols, Summary Reports, Trace Matrices, SOPs, Risk assessments)
Collaborates with Business Users, System Owner, Global IT teams and Business Analysts to define validation requirements and plans
Providing leadership, oversight, and training related to validation activities to multi-functional teams
Generate and execute validation protocols (IQ/OQ/PQ) using Good Documentation Practices (GDP)
Ensuring that the quality system elements necessary to achieve and maintain compliance across multiple businesses, including regulated environments, are established and activities related to computer systems/software testing are controlled via these elements
Working with appropriate teams to establish quality expectations related to validation planning and execution
Participating with stakeholders in the preparation of software specification documents, risk management and validation plans
Participating in developing qualification processes and implementing standard operating procedures
Participate in execution of gap assessment and remediation activities
Investigate and resolve exceptions, non-conformances, deviations, CAPAs and change controls related to validation protocols
Authoring, reviewing, and/or approving system change, configuration management and supporting documentation activities
Preparing for and participating in external/internal computer system/software audits
Serve as the SME for CSV activities and maintain knowledge and information in the CSV area of expertise
Contributing to process improvements by developing and updating written procedures related to computer systems
Skill competencies
At least 10 years of experience in Computer System Validation role in the pharmaceutical, biotech, medical device, or other regulated industry
Demonstrated experience in software quality assurance processes, SDLC methodology, change management, documentation, verification, and validation techniques
Understanding of GAMP 5 techniques and software industry standards and their impact on internal procedures, and software quality
Demonstrated project management and leadership skills
Proficiency in interacting with contacts, including project teams and vendors
Certified auditor or equivalent experience conducting software-vendor quality audits
Working knowledge of the FDA Quality System Regulation, 21 CFR Part 11, EU GMP, Annex 11 and the European and Canadian Medical Device Directives
Understanding of current software quality techniques and industry standards such as ISO, ASQ, AAMI, and GAMP
Experience with the following software systems/applications:
Quality Management System
Document Management System
Validation Management System
Bachelor’s/master’s degree in computer science engineering or equivalent
Thanks,
Ashley
228 Irby Lane, Irving, TX 75062
| Thanks, Ashley
228 Irby Lane, Irving, TX 75062 |
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Siliconstar Tech, 228 Irby Lane, Irving, Texas 75062 Phone: 972 256 8154
