Quality Assurance Specialist

Panda International; Breda; On-site; EUR 80,000 - 84,000; Full time

Benefits offered by this job

Yearly bonus

Commuting allowance

On-site gym

Vitality programs

Company restaurant

Job summary

Panda International is seeking a QA Specialist for a biotech client in Breda. You will lead validation activities for process, equipment, and IS in line with GMP quality and compliance, and review validation documentation.

Responsibilities include maintenance and engineering support, managing changes to equipment and M&E procedures, and performing QA assessments for technical changes. A strong background in GMP, Annex 11/Part 11, and risk management is required.

Qualifications

• Master degree in a relevant field with 5-8 years in GMP environments.
• Proven experience with equipment and automation validation.
• Experience with risk management tools such as FMEA and related methods.
• Familiarity with statistical tools to support sampling plans and hypothesis testing.

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 responsibilities and alignment with GMP regulations.
• Quality Risk Management (QRM) representation and 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: final review of technical change controls and QA assessment coordination.

Skills

GMP experience

Validation management

Risk management

Statistical analysis

Education

Master's degree in Engineering, Pharmaceutical sciences, Process Technology or equivalent

Job description

I am looking for a QA Specialist for my biotech client in Breda.

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.

Qualifications

• 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

What you can expect from us

• Gross annual compensation between 80,124-84.346 including the 13th month and holiday allowance
• Yearly bonus
• Commuting allowance
• A strong focus on well-being, including access to an on-site gym, vitality programs, and a healthy company restaurant