Norac Pharma is recruiting for qualified Validation Manager Candidates for our Quality Assurance Department.
Norac Pharma is a premier Contract Manufacturing Organization for Active Pharmaceutical Ingredients. We are located in Azusa CA, approximately 12 miles east of Pasadena near the 210 and 605 freeway junction. We are a privately held corporation and have been in business since 1957.
We offer a competitive wage and employee benefits package, including Medical, Dental, and Life Insurance coverage, 401(k) and Retirement Plan, Health and Dependent Care Flexible Spending Account Plans, and a generous vacation and holiday schedule.
For more information, please visit our website: www.noracpharma.com
JOB TITLE: Validation Manager
DEPARTMENT: Quality Assurance
The position is responsible for managing the company’s validation and metrology programs to ensure that API products meet the requirements of regulatory agencies, internal company standards and industry current practices.
- Manage validation program that includes qualification of facility, utility, manufacturing and computer systems and validation of cleaning and manufacturing processes.
- Manage calibration and maintenance program (using Calibration Manager™), including procurement of validation equipment and calibration instruments.
- Manage the company’s cleaning validation program that defined the systematic approach in the development and validation of equipment cleaning process, including establishment of cleaning limits.
- Manage (hands-on) the metrology program for in-house calibration and certification of process and analytical instruments, including fume hoods and HEPA filtered enclosures.
- Coordinate, review and approve qualification of laboratory instruments and validation of analytical methods.
Prepare, review, approve and participate in the execution of test plans, standard operating procedures, qualification/validation protocols and reports for:
- Facility Qualification
- Process Equipment Qualification
- Computer Hardware Qualification
- Critical System Utilities Qualification
- Process Validation
- Cleaning Validation
- Software Validation
Write validation master plan for existing and new facilities and new products.
Review, revise and write SOPs on various quality systems, including validation, change control, calibration, maintenance, and other related programs to address specific regulatory requirements and current industry practices.
Participate in the change control program including pre-change evaluation of the impact of the contemplated changes to the validated state of the associated system or process and post-change analysis of completed change.
Write and Issue Technical Reports on subjects related to quality functions
Develop any needed procedures for the Quality Assurance and Validation functions.
Participate in process development and commissioning of systems used in the testing and manufacturing of active pharmaceutical ingredient (API) products.
Reviews and approve engineering drawings.
Assist in the management of paperless recorders used in environmental monitoring of key functional areas.
Interact with all Regulatory Agencies during the course of audits and/or other relevant interactions.
Train internal resources in all aspects of validation and calibration activities.
Actively support the Environmental, Health & Safety programs of Norac Pharma to ensure employee and plant safety and security.
Work with management, technical personnel, and EHS director to ensure compliance with OSHA and other safety regulations (e.g., hot work, lock out tags, confined work space, etc.).
Education / Experience / Personal Requirements:
7+ years in a Pharmaceutical Manufacturing environment
Thorough knowledge and understanding of cGMP’s
Familiarity with Active Pharmaceutical Ingredients
Degree in Engineering or Science
3+ years in Pharmaceutical Validation Management
Practical Experience in the following areas:
- Pharmaceutical Facility Design and Commissioning
- HVAC Systems
- Validated Water Systems
- Qualification of Utility Systems (Steam, Air, Vacuum, Refrigeration)
- Aseptic Design and Techniques
- Equipment Qualification (IQ/OQ/PQ)
- Process Validation
- Cleaning Validation
- Computer Hardware and Software Validation
- Part 11 Compliance Planning and Execution
- Validation Master Planning
- Project Management
- Calibration Methodology
- Preventative Maintenance scheduling
- Environmental Monitoring Programs
- Technology Transfer
- Chemical Synthesis and Purification
- Large Scale Preparatory Chromatography
Working knowledge and application of the following:
- 21CFR Parts 210 and 211 – cGMP for Finished Pharmaceuticals
- FDA regulations and guidance documents
- ICH documents
- USP methodolgy
- ISPE Baseline Engineering Guides
- 21 CFR Part 11 – Electronic Signatures and Electronic Records