- Location: Irvine
- Type: Direct Hire
- Job #33251
Global Pharmaceutical Contract Manufacturer is seeking a Validation Specialist to join their Quality team!
Scope and Purpose of Position
Develops and implements solutions to validation issues.
- Responsible for developing and recommending validation strategies and designing studies for the purpose of providing documented evidence that a system, equipment, method, or process has been validated.
- Conducts and processes qualifications programs, writes detailed protocols and reports to document the validation of systems/ equipment and provides validation support for facility and utility expansion, compliance upgrades, etc.
- Develops and implements solutions to validation issues.
- Operate validation equipment as need and execute protocol for validation.
- Prepare and manage multiple projects, including document/protocol preparation, testing, report generation, analytical method development and statistical data analysis.
- Lead the Validation / Sterilization group by providing training and guidance in completing the assignment.
- Review sterilization chart and release production sterilization cycle
- Work cross functionally to ensure department is delivering assignments on time.
- Makes recommendations and implements solutions.
- Support the Developing new products and processes that are competitive and meet all GMP and ISO requirements.
- Communicate with laboratory and QA personnel/ Engineering/ Operation/management to correct and improve deficiencies.
- Any and all other duties as assigned by immediate supervisor.
Required Knowledge, Skills and Abilities
- Working knowledge of QA/QC principles
- Strong understanding and knowledge in GMP/GLP/ISO guidelines.
- Strong attention to detail
- Excellent written/oral communication skills, computer knowledge (excel, word)
- Able to facilitate in a cohesive manner
- Eager to grow and learn
- Ability to work independently with minimal supervision
- Knowledge and experience of lab safety
Required Education and Experience
- BS degree in Biochemistry, Chemistry, Engineering, Biology or closely related discipline required
- 4+ year experience in Validation and Sterilization Science