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- ...sites, ensuring robustness and regulatory compliance. Ensure readiness and support for regulatory inspections and audits by US FDA, EMA, Health Canada, and other global agencies. Oversee commercial release and stability testing in compliance with global regulatory...SuggestedFull timeLocal areaRelocation
Biosimilar Sciences PR LLC
Puerto Rico7 days ago $35 - $39 per hour
...risk assessments including ability to lead risk assessment execution # Knowledgeable on applicable regulations as defined by FDA, EMA etc and industry guidance and best practise eg ISPE, PDA # Communication skill and presetting to senior QA leadership Monday to...SuggestedMonday to Friday- ...oversight, and technical expertise to generate CMC data suitable for global regulatory submissions. We are committed to compliance with FDA, EMA, and ICH requirements and to fostering a strong culture of quality, contamination control, and continuous improvement. Job...SuggestedLocal areaFlexible hoursWeekend work
Biosimilar Sciences PR LLC
Puerto Rico7 days ago - ...execution and ensure proper documentation of results. # Documentation & Compliance • Ensure all C&Q documentation complies with GMP, FDA, EMA, and internal Amgen standards. • Maintain document lifecycle within electronic systems. • Support data integrity and ALCOA+...SuggestedFor contractorsLocal areaShift work
- ...meet site and corporate needs. 2.3. Compliance, Quality, and Validation ~ Ensure all project activities comply with: o cGMP, FDA, EMA, OSHA, EPA/EQB o 21 CFR Part 11, Engineering, IT, and Security standards ~Support execution of the Computer System Validation (CSV)...SuggestedFor contractorsWork at officeFlexible hoursWeekend work
JC Automation Corp
Puerto Rico7 days ago - ...Perform preventive and corrective maintenance. · Troubleshoot utility systems and implement repairs. · Ensure compliance with FDA, EMA, and cGMP requirements. · Document work using CMMS. · Support validation and commissioning activities. · Maintain logs and...SuggestedLocal area
- ...strengthen validation processes while maintaining regulatory compliance Compliance & Inspection Readiness Ensure compliance with FDA, EMA, MHRA, WHO , and ICH Q7–Q10 requirements Serve as Validation SME during regulatory inspections and client audits Lead...SuggestedContract workLocal areaFlexible hoursWeekend work
- ...Familiarity with Agile/DevOps validation approaches and Computer Software Assurance (CSA) is a plus. ~ Experience supporting FDA, EMA, or other regulatory agency inspections. ~ ASQ CQE/CSSBB or similar quality certification is a plus. Skills Strong working...SuggestedWork at officeLocal area
- ...for the role. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take...SuggestedFull timeContract workInterim roleLocal areaImmediate startRemote workFlexible hours
- ...should arise. Get to know Syneos Health Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000+ Trial patients. No matter what your role is, you’ll take...SuggestedFull timeContract workWork at officeFlexible hours
