Top 24468 Manager validation process Jobs

Validation Manager
Hikma Pharmaceuticals —Bedford, OH
- $92,850 - $133,750 a year
- Full-time
- OSHA
- Engineering
- Research
- Health insurance
- Dental insurance
Quick Apply
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Resilux America LLC —Pendergrass, GA
- From $145,000 a year
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Quality Manager
Confidential —Asheville, NC
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- Analysis skills
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Estimator
Advanced Integrated Technologies (AIT) —Norfolk, VA
- $90,000 - $110,000 a year
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- Mid-level
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FPGA Design Manager / Section Lead
BAE Systems Inc. —Totowa, NJ
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Biorepository Operations Director
Confidential —Arlington, VA
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Mill —San Bruno, CA
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Solutions Architect
RWD Consulting, LLC —Bethesda, MD
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- 7 years
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- Health insurance
- Dental insurance
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Marine Electrical Systems Expert
Regal Boats —Orlando, FL
- Overtime
- 5 years
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Manager - Engineering
Catalent —Madison, WI
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Product Manager- Advanced Product Development
Amphenol Sine Systems —Clinton Township, MI
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Cadre Staffing Inc. —New York, NY
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SAP Project Manager
Natuvion —Miami, FL
- $90,000 - $140,000 a year
- Full-time
- Hybrid work
- Spanish
- PMP
- Office
- Health insurance
- Dental insurance
Quick Apply

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Validation Manager

Hikma Pharmaceuticals
Bedford, OH

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Job Details

Full-time
$92,850 - $133,750 a year
8 days ago

Benefits

Health insurance
Dental insurance
401(k)
Paid time off
Vision insurance
Life insurance

Qualifications

OSHA
GMP
Pharmaceutical company experience
Requirements analysis
Project scheduling
FDA regulations
Pharmaceutical manufacturing facility experience

Full Job Description

Position Summary

The Validation Manager is responsible for the Validation Master Plan (VMP) and managing qualifications and re-qualifications. This includes the review and approval of validation protocols, reports, and related documentation such as: User Requirements Specification (URS), Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ), as well as Re-qualification (RQ) of process equipment, facility equipment and utility systems. Responsibility encompasses completion of validation activities that meet the requirements of the cGMP's as well as the pharmaceutical industry standards and comply with site validation policy.

Key Responsibilities

· Coordinate and maintain critical validation responsibilities such as planning, scheduling, identifying resource requirements (people and equipment), coordinating with other departments, and ensuring compliance with applicable VMPs.

· Provides input to, reviews and approves User Requirements Specifications (URS).

· Review and approves protocols including Cycle Development Protocols, Investigational/Engineering Study Protocols, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ).

· Provides input to Engineering on the preparation and execution of Factory Acceptance Test (FAT), Site Acceptance Test (SAT) and Commissioning protocols.

· Researches equipment and processes, and establishes parameters and methods to test equipment to meet validation requirements.

· Ensures an effective coordination of the execution of qualifications and all aspects of the validation project with other departments, including but not limited to: Operations, Engineering, Quality Control and Quality Assurance.

· Ensures that the execution of protocols and all related documentation is in compliance with current Good Documentation Practices.

· Ensures equipment used for qualification purposes is properly maintained and calibrated.

· Supports and participates in change control process for critical system/equipment updates and repairs performed through the Work Order control mechanisms. Fully understands the requirements of each change control procedure.

· Assists in equipment troubleshooting and the use of problem solving techniques to resolve issues that could impact the validated state of equipment.

· Performs other duties as assigned and required.

· Ensure processes and products are in compliance with all local, state, and federal rules and regulations. Oversee that processes are in CGMP compliance, and establish systems that identifies opportunities for improvement and makes constructive suggestions for change to improve process effectiveness to heighten quality. Develop knowledge of and understand regulatory requirements such as 21CFR part 210 and 211, cGMP’s, FDA, OSHA and other regulatory agencies.

· Personnel engaged in the manufacture, processing, packing, or holding of a drug product shall wear clean clothing appropriate for the duties they perform. Protective apparel, such as head, face, hand, and arm coverings, shall be worn as necessary to protect drug products from contamination.

Requirements

· 4-6 years of validation experience in the pharmaceutical or other GMP-regulated industry

· Experience with aseptic processes is preferred

· Bachelor’s Degree in engineering, science or another discipline with equivalent work experience

· Knowledge of Microsoft Project, Trackwise, AMMS preferred

· Demonstrated ability to communicate effectively with others

Physical Requirements of the Role

Position is exposed to plant environment. This role is continuously sitting and typing. Frequently talking and using eye and hand coordination. Occasionally requiring lifting and carrying less than 25 lbs. Standing, walking, bending over and repetitive use of legs are done occasionally.

Any person shown at any time (either by medical examination or supervisory observation) to have an apparent illness or open lesions that may affect the safety or quality of a drug product shall be excluded from direct contact with components, drug product containers, closures, in-process materials, and drug products until the condition is corrected or determined by competent medical personnel not to jeopardize the safety or quality of drug products. All personnel shall be instructed to report to supervisory personnel any health conditions that may have an adverse effect on drug products.

Pay: $92,850.00 - $133,750.00 per year

Benefits:

401(k)
Dental insurance
Health insurance
Life insurance
Paid time off
Vision insurance

Work Location: In person

Quick Apply

Refine Your Search

manager validation process jobs

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