At Zebra, we never ask for sensitive personal or banking information until after the interview process is complete and an offer has been issued. To protect candidates from falling victim to online fraudulent activity involving fake job postings and employment offers, please be aware our recruiters will always connect with you via email accounts. We develop new technologies and create new solutions with partners to help organizations act with great visibility, connectivity, and intelligence. Strong computer skills and working knowledge of Microsoft Office Suite and Adobeĭemonstrated ability to work on complex assignments in collaboration with various departments.īachelor's degree in the life sciences (or equivalent work experience) with a minimum of 10 years of pharmaceutical manufacturing experience and at least 8 years of those years in a progressive challenging QA department in the pharmaceutical industry.At Zebra, we extend the edge of possibilities by shaping the future of work on the front line – reinventing how business run and moving society forward. We're a community of changemakers, innovators, and doers who come together to deliver a performance edge to the front line of business.
Multiple priorities and re-prioritize tasks Work and communicate with cross-functional teams. Writing and maintaining cGMP documentation.Īnalyze data/information and resolve complex issues.
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Oversee the global labeling requirements for OTC (Monograph and ANDA) products packaged for private label customers and Granules.Įnsure drug listing is completed for all Granules marketed products related to OTC ANDA and OTC MonographĮxpert-level knowledge of the FDA guidance for Industry, Title 21 of the Code of Federal Regulations and Compendia (USP/EP/BP/etc.)ĬGMP compliance within the pharmaceutical manufacturing industry. Implement and maintain a complaint processing system to ensure effective and timely resolution of all complaint investigations. Prepare management reports regarding compliance operations and progress.Īssist with external audits for compliance reviews. Research and keep abreast of compliance regulation updates. Train employees on regulatory and compliance-related policies and procedures. Provide quality support for products (Bulk, Packaged, Pre-Formulated Ingredients and API) distributed in North America.Ĭoordinate review and approval of quality agreements for API, PFI, Bulk and CPO’s (Contract packaging organizations) providers.Įnsure customer complaints are timely investigated and adequate CAPA are implemented. Maintain documentation of compliance activities and file appropriate compliance reports with regulatory agencies. Review and assess product, compliance, and operational risk to develop risk management strategies. Oversee quality packaging operations for the products packaged for OTC products distributed. Manages and oversees procedures for change controls, deviations/investigations, CAPA, labeling, retain samples, vendor qualification, customer complaints, batch packaging records, stability studies, regulatory agency inspections, product recalls, and annual product review. Responsibilities include but not limited to:ĭevelop and implement Standard Operating Procedures (SOPs) for Quality Systems required for pharmaceutical products manufacturing, packaging and distribution. **Remote/Hybrid role with occasional travel to New Jersey**
This person should be knowledgeable of cGMP requirements, FDA regulations and ICH guidelines. Assures that all facilities adhere to compendial and regulatory compliance through the review of appropriate documentation. This position is responsible for overseeing all quality system functions per cGMP and related company SOP’s, state, federal and local laws as applicable. The Senior Manager, Quality Assurance is responsible to ensures compliance with cGMP and internal policies, procedures, and specifications at Granules facilities and contract manufacturing facilities.
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