Description
We are looking for tenacious candidates to fill this validation role with an exciting mid sized Pharmaceutical company in the Bay Area. This is a financially stable company currently in a rapid growth mode. A few expected responsibilities are as follows:
- Develops, executes, and analyzes validation projects to demonstrate process consistency, equipment, facility, and cGMP compliance to FDA and EMA regulations and ICH guidelines.
- Provides oversight and applies lifecycle concept for process validation activities of drug substance and drug product manufacturing.
- Reviews and approves analytical test method validation protocols and reports.
- Evaluates internal equipment and systems, identifies critical features, and defines appropriate test plans, protocols, data records, and deliverables.
- Applies risk-based analysis to assess and prioritize the requirements for validation.
- Reviews test requirements and scripts, identifies, resolves and approves test discrepancies to ensure accurate records and summaries of test results.
- Collaborate with cross functional teams to develop requirements (URS/FRS) for systems, applications and equipment.
- Applies quality standards, procedures, and knowledge of current industry/regulatory standards for validation implementation, execution and completion.
- Administers and coordinates the metrology (calibration) program.
- Maintains awareness of regulatory and compendial requirements.
- Reviews change controls for new and upgraded processes, analytical methods, computer systems, equipment, and facilities to meet internal company and external government requirements.
Please reply for more info and to apply for an interview! If you have the right background we will be looking to move quickly and bring on the right people immediately!
Thank you for your time b.ross(@)realstaffing.com
To find out more about Real please visit www.realstaffing.com