Situation:In this function Glenn acted as QA Specialist for MSD, reviewing and approving all types of qualification and validation documents mainly for automated, computerized and laboratory systems.Requiring the ability to make independent decisions regarding problems that arise during the daily tasks, making sure documentation meets expected global and local requirements.Specializations and domains: Automated Systems, Computerized Systems, Lab and Manufacturing Equipment, Data IntegrityTasks, responsibilities and activities:- Review and approval of qualification and validation documents.- Review, approval and follow-up of issues arising during qualification (e.g., deviations and CAPA's)- Active participation in meetings.- Assuring systems are set up and used compliant with Data Integrity requirements.- Proposing and elaborating improvements in review cycle and validation approach.- Assisting Validation engineers in preparing compliant validation documentationResult:Approved documents comply with MSD Standards and regulatory requirements. Documentation is audit ready.Skills:- Planning- QA- Critical Thinking- Communication- Coordination- Leadership- Negotiating- MS Office- TrackwiseSector experience:- Pharmaceuticals

Situation:Validation Specialist for Laboratory and Climatic Systems at Janssen Pharmaceutica.In this function he had to prepare and execute different types of qualification and validation documents (e.g. URS, validation plans, protocols and reports). The Validation Specialist is able to make independent decisions regarding problems that arise during the daily tasks and follow-up of the projects.Specializations and domains: Laboratory Systems, Climatic SystemsTasks, responsibilities and activities:- Preparing and executing of qualification and validation documents.- Identifying and solving of problems during the validation.- Making decisions regarding issues during projects.- Active participation in work groups and meetings.- Responding to questions from management and QA.- Proposing and elaborating improvements in order to optimize validation methods and approaches.- Communicating the status of documents.Result:Qualification and validation documents are approved and comply with regulatory requirements. Validation methods and approaches are optimized through continuous improvement.Skills:- Validation/Qualification (Lab Systems, Climatic Systems)- Planning- MS Office- SAP- Analytic Thinking- Communication- Coordination- NegotiatingSector experience:- Pharmaceuticals (CMO)

Situation:RA/GDP/GMP Officer & RP for MPCA Consulting firm for various types of customers (large, international and small companies).In this function the main focus was review of master production batch records and batch records. Next to performing audits, maintaining and following QMS and executing regulatory checks. Requiring the ability to make independent decisions regarding problems that arise during the daily tasks, follow-up and prioritization of tasks to meet market and customer requests.Specializations and domains: GMP & GDP QMS, Batch Record Review, Internal & External Audit, EU Import of MedicinesTasks, responsibilities and activities:- Review and approval of Master Batch Records- Review and approval of qualification and validation documents.- Informing and advising QP on issues encountered during production.- Active participation in meetings.- Responding to questions from customers and health authorities.- Proposing and elaborating improvements in order to optimize batch record review cycle.- Maintaining compliant QMS (CAPA, Change Control, Deviations, Complaints...)- Issuing and following up on CAPA, Change Control, Deviations, Complaints- Preparing and executing internal audit of different departments as (deputy) RP.Result:Quality of released products is assured to be compliant with EU Regulations.Skills:- Batch Record Review- Planning- QMS- Audit- Critical Thinking- Communication- Coordination- Leadership- Negotiating- MS OfficeSector experience:- Pharmaceuticals- Biotech- Medical Devices- GDP

Situation:Project Validation Engineer (PVE) for all types of validation at Purna Pharmaceuticals as well as assisting QP with regulatory questions and license updates.In this function he had to prepare and execute different types of qualification and validation documents (e.g. URS, validation plans, protocols and reports). The VAE is able to make independent decisions regarding problems that arise during the daily tasks and follow-up of the projects.Specializations and domains: Process Validation (production and packaging validation), Facility Qualification, Equipment Qualification, Laboratory Equipment Qualification and Computer System Validation.Tasks, responsibilities and activities:- Preparing and executing of qualification and validation documents.- Identifying and solving of problems during the validation.- Making decisions regarding issues during projects.- Active participation in work groups and meetings.- Responding to questions from management and QA.- Proposing and elaborating improvements in order to optimize validation methods and approaches.- Communicating the status of documents.- Assisting in complaint investigations.- Leading change control meeting.- Assisting in improving QMS- Preparing and requesting license updates to Health authoriesResult:Qualification and validation documents are approved and comply with regulatory requirements. Validation methods and approaches are optimized through continuous improvement.Functional skills:- Validation/Qualification (Process, Manufacturing Equipment, Lab Systems, Facility, Computerized Systems)- Planning- QA- Training- QMSSector experience:- Pharmaceuticals (CMO)Soft skills:- Analytic Thinking- Communication- Coordination- Leadership- NegotiatingTechnical skills :- MS Office- SAP- Chromeleon CDS