Validation Specialist - Equipment Qualification (m/f)

Work location: Savski Marof

As a Equipment Qualification Associate you will be responsible for Qualification and Validation of the Facility, Systems and Equipment. Your duties as the Equipment Qualification Associate will be varied, however the key duties and responsibilities are as follows:

• Facility / Utilities/ Systems qualification and Equipment Qualification in the manufacturing (Biological Drug substance and Aseptic Sterile drug product), warehousing and other manufacturing related areas:
  • Coordination and implementation of qualification activities related to facility / systems and equipment.
  • Planning and execution of qualifications (IQ/ OQ/PQ), requalification, periodic qualifications and periodic reviews
  • Coordination of qualification activities with the external contractor, participation in the testing (FAT, SAT, IQ/OQ/PQ) and supervision of qualification activities 
  • Preparation and authoring of qualification / validation related documentation in Pfizer e-documentation system
  • Participation in FAT, SAT and testing witness in the QC Laboratory HPLC, UPLC systems and other lab equipment to ensure that existing and new equipment are fully qualified
• Documentation for Facility/Utilities/ Systems/ Equipment Qualification
  • Preparation and authoring of all qualification related documentation (write and execute URS, DQ, SRA, IQ, OQ, PQ validation summary reports)
  • Review of documentation and records of the tests performed
  • Preparation of periodic review reports
• Assessment of changes related to the qualification of Facility/Utility/ Systems/ Equipment.

Deliverables include but not limited to: development of a validation plan; utilization of SOPs; documented training on SOPs; development of detailed specifications (URS); development of protocols/ test plan and/or test scripts and reports as well as other validation/qualification related documentation.

Your success will be evaluated based on your ability to manage validation deliverables within the expected time and compliance to Pfizer Standards, EU GMP, 21 CFR part 211, EU GMP Annex 15 and other relevant regulatory requirements.

 

Duties and Responsibilities

• Planning, creation and execution of qualification documentation deliverables (IQ/OQ/PQ plans, protocols, tests, reports, etc.) including participation in testing aligned with Pfizer Standards, EU GMP, 21 CFR part 211, EU GMP Annex 15 and other relevant GMP requirements.
• Ensure Facility / Utilities/ Systems/ Equipment Qualification and Validation document deliverables are following site and corporate policies and procedures following Risk-based Lifecycle Approach from URS (User Requirement Specifications) development through system retirement.
• Maintain Equipment Qualification in Change Management Process.
• Work closely with business stakeholders and technical support groups to thoroughly investigate validation discrepancies and drive best-practice for validation.
• Self-motivated / self-starter person will work independently under Validation department, with ability to work on problems of diverse scope where a solution is not readily apparent.
• Strong commitment to continually improve compliance with GMP and data integrity principles. 
• Proactively develop approaches and risk mitigation strategies.

Qualifications

• University degree required in Technical Sci (Electrical /Mechanical Eng.) or Life Science
• Analytical and quantitative problem-solving skills
• Ability to work creatively in a problem-solving environment
• Competency in MS Office applications
• Basic knowledge of statistics
• Fluent Croatian and proficiency in English
• Previous working experience in validation / qualification in pharmaceutical industry is preferred

Skills/Competencies

• Technical proficiency, attention to detail, creativity, innovation, and independent thought.
• Working knowledge of GMP, FDA and EU regulations including 21 CFR Part 11
• Working knowledge of equipment qualification specifically for pharmaceutical industry is preferred
• Strong communication skills - Demonstrates strong written and verbal communication skills.
• Tendency for teamwork
• Adaptable, systematic and punctuate

• Organized transport to and from the site 

• Work with modern automated systems  

• Opportunity for working on projects with other Pfizer sites and locations  

• Strong education program  

• Christmas, Easter and holiday bonus  

• Affordable meals in an on-site cafeteria  

• Opportunities for career enhancement and development  

• Yearly pay increase and bonus based on performance 

• Further professional development in a supportive environment  

• Free health check-ups 

• Free psychotherapy and coaching sessions for employees and people close to them 

• Bravo employee recognition system  

• Free fruit and hot beverages on the site 

• Insurance from accident 24/7 

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

Quality Assurance and Control