Sr. QA Associate Validation
I am looking for a (Sr.) Associate QA (Validation / Packaging / PASX master data).
Responsibilities
- Process, equipment, and IS validation
- Agrees on strategy and guides 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, …).
- Device and combination product.
- Manages ABR’s device responsibilities and ensures alignment with GMP regulations.
- PASX master data.
- Review and approve master data in the PASX system as QA.
- 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.
- Deviation management.
- Functions as QA contact for deviation records.
Minimum Requirements
- MBO or Bachelor’s degree in Life Sciences or process technology-related field or the equivalent combination of education and/or experience.
- Typically 3 years of relevant experience in the pharmaceutical or medical device industry with experience in Equipment and Automation Validation.
- Good Manufacturing Practice (GMP), equipment and automation/IS validation, computer compliance (Annex 11, Part 11) knowledge with the ability to interpret and apply in mainly routine cases.
- Manufacturing and/or Quality analytical processes and operations.
- Fluent in the English language.
Preferred Requirements
- Experience with the pharmaceutical industry.
- Experience with Deviations and Change Control.
If you are interested in this opportunity, please send your CV to k.mabena@panda-int.com today! Let's connect as soon as possible.
If you know someone who might be a good fit, feel free to introduce me to them. You can also refer a friend and earn €250,- for successful referrals.