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QA&RA Manager Our company is looking for a QA & RA Manager to expand its activities. The candidate will : • Develop, implement and manage the quality systems, working with internal and external customers and partners, to ensure compliance with regulatory requirements • Manage the Quality System with a focus on ongoing improvement and responsible for ensuring compliance with CGMPs, FDA requirements, and internal SOPs • Ensure that Annual Product Reviews, SOPs, Change Controls, Complaints, Investigations, CAPAs, Stability Management, IQ/OQ/PQ protocols and reports, and validation protocols and reports are managed in compliance with regulatory requirements • Ensure batch record review and release process to ensure timely release of product to the market • Provide quality oversight of all external partners, including contract manufacturers, packagers and testing labs providing product or services to the company. •Develop and report metrics to senior management on the status of compliance; advise management of potential issues; ensure the implementation of appropriate corrective actions •Support in the preparation of all required FDA correspondence on compliance matters; serve as the host for regulatory (FDA, DEA, etc.) inspections •Perform GMP audits of vendors/ suppliers, including participating in due diligence audits as required •Assembly the ANDAs and other regulatory filings for drugs: collecting relevant information from the other departments, writing of the Chemistry, Manufacturing and Control Sections, and reviewing complete application for accuracy and completeness following Regulatory Authority Guidelines. •Act as a contact point with the FDA on regulatory applications for assigned products - under minimal supervision, resolve issues/inquiries/deficiency letters and follow-up to ensure initial applications are approvable. Manage submissions to meet timelines. •For the approved applications, act as the responsible person for all regulatory topics to be managed with the US licensees. Additional Requirements •B.S. /M.S. in scientific discipline (Chemistry, Biology or Pharmaceutical or other life science •At least 5 year experience in US pharma, cGMP environment. •Thorough understanding of GMP requirements, 21 CFR 210 & 211; strong knowledge of FDA & DEA & ICH guidelines. •Excellent verbal and written communication skills, organizational and time management skills; strong attention to details and customer focus. •Ability to work with limited supervision in a small-business environment Competitive package come with this position.
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