Offerte di lavoro / Equipment Validation Compliance Specialist
CercoLavoro
Equipment Validation Compliance Specialist
Azienda non indicata
Descrizione
Key Responsibilities
Review technical documentation related to equipment and systems requiring qualification, ensuring compliance with current regulatory requirements (cGMP, FDA, etc.) and internal procedures.
Review and approve qualification protocols and reports (IQ, OQ, PQ), guaranteeing their accuracy, completeness and compliance with GMP regulations and company standards.
Support equipment qualification activities by providing quality oversight and evaluating technical issues to ensure proper execution of IQ/OQ/PQ protocols.
Assist the Team Leader during customer and regulatory inspections by preparing required documentation, providing information and participating in audits.
Monitor implementation of procedures within the area of responsibility, ensuring adherence to corporate quality policies.
Maintain and continuously update SOPs, operating procedures, methods and validation documentation through preparation and periodic review.
Requirements
Bachelor’s or Master’s degree in Pharmaceutical Chemistry, Pharmacy, Chemistry, Biotechnology, Biology, Engineering or related scientific field.
At least 5 years of experience in the pharmaceutical industry, preferably within Quality Assurance and Equipment Validation.
Knowledge of equipment and system validation principles (IQ, OQ, PQ) and of FDA/EMA regulations.
Good knowledge of cGMP, data integrity (21 CFR Part 11) and risk‑assessment methodologies (FMEA).
Proficiency with Microsoft Office suite; English intermediate (written and spoken).
Ability to work independently and in cross‑functional teams, with high attention to detail and ability to manage multiple priorities.
Travel between sites may be required; flexible schedule for time‑sensitive validation activities.
Review technical documentation related to equipment and systems requiring qualification, ensuring compliance with current regulatory requirements (cGMP, FDA, etc.) and internal procedures.
Review and approve qualification protocols and reports (IQ, OQ, PQ), guaranteeing their accuracy, completeness and compliance with GMP regulations and company standards.
Support equipment qualification activities by providing quality oversight and evaluating technical issues to ensure proper execution of IQ/OQ/PQ protocols.
Assist the Team Leader during customer and regulatory inspections by preparing required documentation, providing information and participating in audits.
Monitor implementation of procedures within the area of responsibility, ensuring adherence to corporate quality policies.
Maintain and continuously update SOPs, operating procedures, methods and validation documentation through preparation and periodic review.
Requirements
Bachelor’s or Master’s degree in Pharmaceutical Chemistry, Pharmacy, Chemistry, Biotechnology, Biology, Engineering or related scientific field.
At least 5 years of experience in the pharmaceutical industry, preferably within Quality Assurance and Equipment Validation.
Knowledge of equipment and system validation principles (IQ, OQ, PQ) and of FDA/EMA regulations.
Good knowledge of cGMP, data integrity (21 CFR Part 11) and risk‑assessment methodologies (FMEA).
Proficiency with Microsoft Office suite; English intermediate (written and spoken).
Ability to work independently and in cross‑functional teams, with high attention to detail and ability to manage multiple priorities.
Travel between sites may be required; flexible schedule for time‑sensitive validation activities.
Fonte: CercoLavoro