Back to Job SearchA leading company in the pharmaceutical industry based in the Walloon region, Belgium, is seeking a Qualification-Validation Lead to join their team. This role offers a unique chance to be part of a dynamic environment where your expertise will directly impact the success of strategic projects. As the Qualification-Validation Lead, you will be responsible for driving the strategy and execution of qualification and validation activities for a major expansion project of a biological drug substance production building.
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Qualification-Validation Lead will be varied however the key duties and responsibilities are as follows:
1. As the Qualification-Validation Lead, you will define and deploy the qualification and validation strategy, ensuring alignment with quality, regulatory, and operational requirements.
2. As the Qualification-Validation Lead, you will lead and coordinate all qualification activities (FAT, SAT, IQ, OQ, PQ) for complex equipment and critical systems in a multidisciplinary environment.
3. As the Qualification-Validation Lead, you will provide operational leadership, managing priorities, risks, and resources in collaboration with the project team.
4. As the Qualification-Validation Lead, you will ensure excellence in execution, including deviation management, adherence to timelines, and quality/integrity of deliverables.
ROLE REQUIREMENTS:
To be successful in your application to this exciting opportunity as the Qualification-Validation Lead we are looking to identify the following on your profile and past history:
1. Relevant degree in a scientific field.
2. Extensive industry experience in validation.
3. A working knowledge and practical experience with pharmaceutical industrial processes, IT/Computer System Validation, and cleaning and sterilisation validation processes.
Key Words:
Qualification-Validation Lead / CQV Lead / CQV Manager / Commissioning Qualification Validation / C&Q / GMP / Biopharmaceutical / Biotech Manufacturing / Drug Substance / Fill-Finish / Clean Utilities / Process Equipment / Utilities Qualification / CIP / SIP / Sterilisation / Cleaning Validation / Aseptic Processing / Contamination Control / Validation Master Plan (VMP) / Risk-Based Validation / ASTM E2500 / GAMP 5 / Data Integrity / Deviation Management / CAPA / Change Control / Technical Leadership / Stakeholder Management / Cross-Functional Coordination / Project Planning / Schedule Tracking / KPI Reporting / Dashboarding / Audit Readiness / Regulatory Compliance / FDA / EMA / EudraLex / Annex 15 / Commissioning / Engineering / Process Validation / Equipment Lifecycle / Vendor Management / FAT SAT Execution / IQ OQ PQ Execution / Validation Strategy / Lifecycle Approach / Inspection Readiness / Continuous Improvement / Root Cause Analysis / Biologics Facility / GMP Environment / Pharmaceutical Engineering / Validation Documentation / SOPs / Multisite Projects / Risk Management / Project Delivery
KEY DUTIES AND RESPONSIBILITIES:
Your duties as the Qualification-Validation Lead will be varied however the key duties and responsibilities are as follows:
1. As the Qualification-Validation Lead, you will define and deploy the qualification and validation strategy, ensuring alignment with quality, regulatory, and operational requirements.
2. As the Qualification-Validation Lead, you will lead and coordinate all qualification activities (FAT, SAT, IQ, OQ, PQ) for complex equipment and critical systems in a multidisciplinary environment.
3. As the Qualification-Validation Lead, you will provide operational leadership, managing priorities, risks, and resources in collaboration with the project team.
4. As the Qualification-Validation Lead, you will ensure excellence in execution, including deviation management, adherence to timelines, and quality/integrity of deliverables.
ROLE REQUIREMENTS:
To be successful in your application to this exciting opportunity as the Qualification-Validation Lead we are looking to identify the following on your profile and past history:
1. Relevant degree in a scientific field.
2. Extensive industry experience in validation.
3. A working knowledge and practical experience with pharmaceutical industrial processes, IT/Computer System Validation, and cleaning and sterilisation validation processes.
Key Words:
Qualification-Validation Lead / CQV Lead / CQV Manager / Commissioning Qualification Validation / C&Q / GMP / Biopharmaceutical / Biotech Manufacturing / Drug Substance / Fill-Finish / Clean Utilities / Process Equipment / Utilities Qualification / CIP / SIP / Sterilisation / Cleaning Validation / Aseptic Processing / Contamination Control / Validation Master Plan (VMP) / Risk-Based Validation / ASTM E2500 / GAMP 5 / Data Integrity / Deviation Management / CAPA / Change Control / Technical Leadership / Stakeholder Management / Cross-Functional Coordination / Project Planning / Schedule Tracking / KPI Reporting / Dashboarding / Audit Readiness / Regulatory Compliance / FDA / EMA / EudraLex / Annex 15 / Commissioning / Engineering / Process Validation / Equipment Lifecycle / Vendor Management / FAT SAT Execution / IQ OQ PQ Execution / Validation Strategy / Lifecycle Approach / Inspection Readiness / Continuous Improvement / Root Cause Analysis / Biologics Facility / GMP Environment / Pharmaceutical Engineering / Validation Documentation / SOPs / Multisite Projects / Risk Management / Project Delivery
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the STEM sectors, combining recruitment expertise with scientific knowledge to help you advance your career.
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