As a Validation Specialist you will be responsible for Validation of manufacturing Processes including Biological Drug Substance, Aseptic Sterile Drug Products, and Combination product, Cleaning validations, and transport validations. Your duties will be varied however the key duties and responsibilities are as follows:
- Coordination and implementation of validation activities related to Biological Drug Substance manufacturing process, Aseptic Sterile Drug Products manufacturing process, Combination product manufacturing process, Cleaning validations, and transport validations
- Planning and execution of validations, periodic verifications and periodic reviews
- Coordination of activities with the external contractor where required, participation in the testing and supervision of validation activities
- Preparation and authoring of validation related documentation in Pfizer e- documentation system
- Assessment of changes related to the Process/Systems/ Equipment with impact on process/ cleaning/ transport validation.
- Perform special projects and studies as assigned by department manager.
Deliverables include, but not limited to: development of a validation plan; utilization of SOPs; documented training on SOPs; development of protocols/ test plan and/or test scripts and reports as well as other validation related documentation. Your success as 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:
- Manage all Process/ cleaning /transport validation schedule and coordinate activities with QA and QC and/or external laboratories and operations.
- Review, analyze, and prepare validation protocols, reports, and other validation documents
- Work closely with business stakeholders and technical support groups to thoroughly investigate validation discrepancies and drive best-practice for validation.
- Support various quality systems relate to validation execution to ensure timely closure of final reports relate to EMA/ FDA consent decree.
- 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.
- University degree required in Biochemistry, Pharmacy, Biology, Chemistry, Engineering, Microbiology, or related 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 in pharmaceutical industry (5+ years)
- Working knowledge of GMP, FDA and EU regulations including 21 CFR Part 11
- Working knowledge of process / cleaning/combo product validation specifically for Pharmaceutical industry
- Technical proficiency, attention to detail, creativity, innovation, and independent thought.
- Strong communication skills - Demonstrates strong written and verbal communication skills.
- Tendency for teamwork
- Adaptable, systematic and punctuate
Please send your application and CV in English via application link and search for JOB ID: 4824419.
Pfizer is an equal opportunity employer and complies with all
applicable equal opportunity legislation in each
jurisdiction in which it operates.