Write, review and execute Validation Protocols and Reports for the new GWWO Albumin Purification and Aseptic Filling Plant ensuring compliance to all relevant global and local quality and validation procedures /standard. Initial requirements to focus on the areas of Equipment, Utilities, CSV and Cleanroom Validation. Minimum two years hands-on validation experience preferred.
What your responsibilities will be
- Write, review and execute Validation Protocols and Reports for the new Albumin Plant (for Equipment, Utilities, Processes, Cleaning, Temperature Mapping and Equipment Software) ensuring compliance to all relevant global and local quality and validation procedures/standards
- Review change controls and assess impact of changes that affect validated systems and define validation requirements
- Represent Validation at both internal and external audits by regulatory agencies, including HPRA and FDA.
- Generation and review of project documentation (User Requirement Specifications, validation protocols, reports etc.) and Standard Operating Procedures.
- Supporting validation activities including review of documentation and hands-on execution of validation activities (FAT, SAT, IQ, OQ, PQ etc) to ensure equipment meets current GMP requirements and industry standards.
- Maintain the Site Validation Master Plan (VMP) and associated Project VMP's, defining the validation approach associated with each piece of equipment, system, process and the requalification requirements including study requirements and frequency. Execute/Co-ordinate Re-Validation activities as required.
- Completion of risk assessments, closure of corrective and preventive actions.
- Investigates and troubleshoots problems and determines solutions or recommendations for changes and/or improvements.
- Performs other validation associated activities as defined by Manager or Director.
- Computer System Validation
- Clean Utilities
- Autoclave / Thermal Mapping
- Process and Cleaning Validation
- Commissioning and Qualification
- Documentation (Writing SOPs, Protocols, Reports)
- Clean Room Qualification
Who you are
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
- Hands-on knowledge of execution of Validation
- Experience in a Quality or Validation Role within Pharma sector
- Experience with Software validation for manufacturing
- Excellent Technical Writing and analytical skills.
- Familiarity with cGMPs and industry and federal guidelines required.
- Experience with Word, Excel and Access computer applications.
- Strong interpersonal skills for interactions with other departments.
- Degree in Science/Engineering
- Experience in representing client companies during internal (Corporate) audits and external (FDA and HPRA) audits an advantage
- Working knowledge of HTM 01 (Part C, Steam Sterilization) Autoclaves an advantage
- Familiarity with ISO-14644 (Cleanrooms and Associated Environments) an advantage
- Familiarity with Annex 1 (Manufacture of Sterile Medicinal Products) an advantage
- Experience within aseptic manufacturing environment an advantage
What we offer
- It's a brilliant opportunity for someone with the right talents.
- We'll help you grow professionally. If you're interested in joining our company and you have what it takes, then don't hesitate to apply. We look forward to receiving your application.
- Grifols is an equal opportunity employer.
- Permanent position with Benefits package