Accountabilities
- Perform QA support and oversight for validation of equipment, automation and information systems and for Quality Risk Management.
- Perform review and approval of equipment and automation validation documentation, ensuring that Corporate, Site and Regulatory requirements are met.
- Provide guidance and direction to operations staff in regards to compliance with quality policies, standards and procedures.
- Provide quality engineering support for testing strategies and quality investigations.
Responsibilities
- Process, equipment and IS validation
- Agrees on strategy and provides guidance regarding design, characterization and validation in cooperation with PD / M&E / IS, while ensuring GMP quality and compliance.
- Reviews and approves validation documentation.
- Maintenance & Engineering support
- Reviews and approves changes to equipment (e.g. parameter changes, like for like assessments, …)
- Reviews and approves changes to M&E procedures (e.g. change over process, preventive and corrective maintenance)
- Device and combination product
- Manages ABR’s device responsibilities and ensures alignment with GMP regulations.
- Quality Risk Management (QRM)
- Represents QA in QRM activities (pFMEA, QRAES, Computer system compliance)
- Ensures alignment of site Quality Risk activities with corporate policy and strategy.
- Reviews quality risk assessment summary reports.
- Change control
- Performs final review of technical change controls, confirming assessments of different stakeholders are complete and all tasks are correctly represented in the record.
- Functions as QA SME and collects input from different QA areas to complete the QA assessment for technical changes.
Authority
- Works under minimal direction
- Work is guided by operational and project objectives
- Manages multiple assignments and processes
- Independently determines approach to project
Outputs
- Delivers quality objectives according to project plan.
- Delivers validated systems, meeting corporate, site and regulatory requirements.
Qualifications
The knowledge and skills necessary to perform the duties of this position are typically acquired through the following combination of education, experience and knowledge, or the equivalent.
Minimum Requirements
- Master degree in Engineering, Pharmaceutical sciences, Process Technology or equivalent
- 5-8 years of professional experience in GMP environment
- Relevant experience in Equipment and Automation Validation
- Proven experience with GMP, equipment and automation/IS validation, computer compliance (Annex 11, Part 11).
- Proven experience with risk management tools such as FMEA, etc.
- Proven experience with statistical tools to support e.g. sampling plans and hypothesis testing.
Preferred Requirements
- Experience with pharmaceutical industry
- Experience with Nonconformances, CAPAs and Change Control
Interested? Send your CV to Daria at d.finikova@panda-int.com or call +31202044502