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DPS Group Global · 6 days ago
Senior Manager, Quality Engineering
Rockville, MD
Full-time
Onsite
Senior Level
3+ years exp
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Responsibilities
Evaluate the current status of the client’s VMP, including general CQV, CSV, and EMPQ to identify gaps, propose mitigation, and initiate remediation.
Work with site facility and operations teams to ensure compliance with Validation Master Plan activities.
Support facility qualification/commissioning and operations/preventative maintenance program.
Support and manage master equipment file.
Implement qualification and validation life cycle for both software and equipment (IQ, OQ, PQ).
Support the site quality system management with measurement and control strategies.
Manage the risk assessment process for qualification and validation.
Review technical/investigation reports as appropriate.
Write, review, and approve proposed changes to systems and procedures, as appropriate.
Write, review, and approve protocols and summary reports.
Perform other duties and tasks as assigned.
Other duties as assigned
Qualification
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Required
Bachelor’s degree in technical discipline (Computer Science/ Industrial Engineering or similar)
Minimum of 3 years of Quality Engineering with related experience such as Computer System Validation in a GMP environment (Drug Substance or Drug Product)
Knowledge of quality systems and pharmaceutical regulatory requirements (21 CRF Part 11/210/211, ICH 8, ICH 9, and ICH 10)
Quality Engineering Certification, ASQ, Black Belt/Green Belt certifications, preferred
Proficiency in Computer System Validation in a GMP environment (Drug Substance or Drug Product)
Automation, equipment, and utility IQ/OQ/PQ/PV
Quality Assurance, GMPs, Health Authority Regulations and Validation practices/principles
Strong knowledge of GMP, GAMP, SOPs, and quality systems
Experience with internal and external audit principles
Strong knowledge of change control practices/strategies
Proficient in MS Word, Excel, PowerPoint, and other applications
Ability to communicate and work independently with scientific/technical personnel
Strong communication and coordination skills, good language skills and the ability to analyze and solve problems with a positive work attitude
Ability to work in a dynamic, fast-paced environment with shifting priorities
Ability to work collaboratively with teams and collaborators
Ability to provide legal US work authorization documents required. Will consider US domestic travelers and relocation
Preferred
Quality Engineering Certification, ASQ, Black Belt/Green Belt certifications, preferred
Benefits
Health and Safety Management
Company
DPS Group Global
DPS is a global consulting, engineering and construction management company, serving high-tech industries around the world.
1,001-5,000 employees
H1B Sponsorship
DPS Group Global has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Trends of Total Sponsorships
2023 (27)
2022 (24)
2021 (23)
2020 (14)
Funding
Current Stage
Late StageTotal Funding
unknown2022-10-05Acquired· by Arcadis ($229.96M)
Recent News
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