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Develop and execute validation protocols (IQ/OQ/PQ, process validation, cleaning validation)
Author validation final reports and ensure timely completion
Lead validation risk assessments and ensure compliance with GMP/GAMP requirements
Investigate deviations and support CAPA implementation
Coordinate with cross‑functional teams (QA, Engineering, Manufacturing)
Maintain and update Validation Master Plans (VMP)
Degree in Engineering, Life Sciences, Biotechnology, or related field
4 - 8 years of validation experience in pharmaceutical or biotech manufacturing
Strong knowledge of GMP, GAMP, and ICH guidelines
Excellent documentation, communication, and problem-solving skills
Job ID: 153310575
Skills:
computerized systems , manufacturing processes , Validation, ALCOA plus, Cgmp, Qualification, Facilities, Cleaning processes, Utilities, Data Integrity Principles, Equipment, cGDP
Skills:
spectrometer , Time Management, Engineering Studies, business efficiency, Organisational Skills, Gmp, Resourceful Problem-solving, Relocation, UV/Vis, business alignment, Chemical Engineering
Skills:
Qc, Gmp, Pharma, GAMP5, Validation
Skills:
Validation Testing, GMP documentation, MES validation, URS review, data integrity principles, Data Mapping
Skills:
Quality System Regulations, equipment installation, PQ, OQ, Sat, IQ, Commissioning, Process Development, Iso 13485, 21 CFR 820, Process Validation, Iso 14971, FAT