Validation Specialist - Equipment Qualification (m/f)
- Croatia - Zagreb
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
What we offer:
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 ControlBreakthroughs that change patients’ lives
Research confirms what intuition tells us: that purpose-driven companies perform better, are more innovative, attract and retain the best people, and know how to unleash the power of those people. Pfizer’s purpose—Breakthroughs that change patients' lives—fuels everything we do and reflects our passion for building on our legacy as one of the greatest contributors of good to the world.
Each word in our purpose has meaning and reflects the value we strive to bring to patients and society:
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“Change” - We want to do more than simply improve patients’ medical conditions; we want to dramatically change their lives for the better.
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Our purpose ensures that patients remain at the center of all we do. We live our purpose by sourcing the best science in the world; partnering with others in the healthcare system to improve access to our medicines; using digital technologies to enhance our drug discovery and development, as well as patient outcomes; and leading the conversation to advocate for pro-innovation/pro-patient policies.
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The “how” is represented by four simple, powerful values—courage, excellence, equity, and joy—that define our company and our culture.
Courage: Breakthroughs start by challenging convention, especially in the face of uncertainty or adversity. This happens when we think big, speak up, and are decisive.
Excellence: We can only change patients’ lives when we perform at our best together. This happens when we focus on what matters, agree who does what, and measure our outcomes.
Equity: We believe that every person deserves to be seen, heard, and cared for. This happens when we are inclusive, act with integrity, and reduce healthcare disparities.
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Our Competitive Benefits Programs help our colleagues by:
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