Compliance Specialist at ALTEN Calsoft Labs

We are a next gen digital transformation, technology consulting, enterprise IT, and product engineering services firm. Our commitment to conducting global business according to the highest legal and ethical standards sets us apart. We strive to make our company a great place to work and are respected for the quality of our people and products. We are looking for a Compliance Specialist to join our team. The ideal candidate will be responsible for reviewing quality critical alarms and NRSR, reviewing J&Cs, entering metrics into the database, initiating and investigating deviations for non-conformance, providing off-hour support for batch record issuance, and functioning as a back-up for the QA Manager. The candidate should have a Bachelor’s Degree in a scientific field with 4-6 years of experience in a Quality and/or other cGMP related field, or a Master’s Degree in a scientific field with 2 years’ experience in the above. Knowledge of external agency regulations (FDA, EMA, etc.), strong computer, verbal and written communication skills, experience in quality systems, leading cross-functional teams, and proficiency in Microsoft Office are required. If you are passionate about maintaining the highest standards of quality and compliance, we encourage you to apply. Responsibilities: - Review of Quality Critical Alarms and NRSR - Review J&Cs - Metric entry into database - Initiate and investigate deviations for non-conformance - Conduct deviation containment assessment (off-hour support) - Provide off-hour support for batch record issuance - Function as back-up for QA Manager - Other activities as assigned

Compliance Specialist

Responsibilities

Skills wanted:

Language(s) required:

About ALTEN Calsoft Labs:

mission:

www.altencalsoftlabs.com

Admin access needed