Driving Infinite Possibilities Within A Diversified, Global Organization

The Quality Assurance (QA) Manager oversees, implements, and maintains cGMP compliant systems and activities. Incumbent is also responsible for evaluating internal controls and maintenance of cGMP documentation for compliance with quality and regulatory standards.  The GMP QA Manager also monitors Contract Manufacturing Organizations (CMOs) ensuring compliance of the manufacturing, packaging and analytical testing of pharmaceutical dosage forms and drug substances. They also identify risks and deficiencies, which they communicate to cross functional teams and management.

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Essential Duties and Responsibilities:

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Following is a summary of the essential functions for this job.  Other duties may be added and performed, which are not mentioned below.  Specific activities may change from time to time.  Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

\n\nEnsures cGMP analytical activities, such as analytical methods, test results and Certificates of Analysis (CoA), Batch Records comply with internal SOPs, company policies and procedures, safety and environmental and regulatory requirements\nReviews cGMP batch manufacturing and packaging records and provides recommendations for approval/rejection and disposition\nManages and approves cGMP investigations, quality incidents, deviations, CAPAs, change control and out-of-specifications/out-of-trends (OOS/OOTs); follows up to verify effectiveness\nAssists with development and implementation of cGMP compliant systems, including internal SOPs, forms, and work instructions\nPerforms Independent audits for compliance to policies and procedures: on paper vs. practice\nAssists corporate quality group in preparation of internal quality audit programs and conducts internal audits per approved schedules in accordance with pertinent quality documents; prepares all corresponding documents and reports\nLeads all external cGMP audits of vendors, including US and International cGMP, GLP, GDP vendor audits, as needed\nCoordinates annual and ongoing cGMP training\nActs as a primary contact for cGMP regulatory inspections\nOversees release of commercial product\nMaintains the quality function for drug products, including but not limited to:\nManages and reviews Product Complaints and Recall program for EU and US products\nReleases or rejects intermediates for use outside of the control of the manufacturing company\nEstablishes a system to release or reject raw materials, intermediates, packaging and labeling materials; Well versed with IPEC, ICH Q7, 21 CFR 210/211 and Eudralex volume 4 Good Manufacturing Practice (GMP) guidelines\nReviews unexecuted and completed batch production and laboratory control records of critical process steps before release of drug products\nReviews and monitors release and stability data\nReviews and approves changes that potentially impact quality of intermediates, drug products\nReviews and approves validation protocols and reports, Specifications, certificates of analysis (CoAs), release of raw materials, and product disposition\nApproves selection of contract manufacturers for intermediates, drug products\nApproves all specifications and master production instructions\nApproves all procedures impacting the quality of intermediates, drug products\nEnsures effective systems are used for maintaining and calibrating critical equipment\nEnsures materials are appropriately tested and the results are reported\nEnsures there is stability data to support retest or expiry dates and storage conditions on drug products, and intermediates where appropriate; performs product quality reviews\nManages and maintain mock recall procedures and policies\nDevelops with the CMC team and CMOs: drug substances (DSs), drug products (DPs), key raw material and intermediates specifications and stability requirements, master batch records, validated manufacturing processes and analytical methods, and CTM and commercial packaging and labeling\nWork closely with internal and external departments to assure compliance with cGMP quality systems and regulations issued by the FDA, and other applicable regulatory bodies\n\n

 

Must Have

\n\nAuditing experience in a GMP and GCP environment\nExcipient cGMP production and quality assurance experience\nKnowledge of US, EMA, NMPA, PMDA, HC, and ICH regulations, guidance and industry standards for CMC, GMP and GCP\n10 + years in pharmaceutical Quality Assurance\n

We Value

\n\nBA or BS degree in a scientific discipline preferred, or comparable experience\nPrevious experience of manufacturing and/or analytical testing is a plus\nProficiency using Office 365, LIMS, SCICORD, SAP, Adobe Acrobat (standard), DYMO labeler, Adobe Acrobat (standard), and various internet browsers\nAbility to travel, including overnight\nAdditional InformationJOB ID: HRD258156Category: Integrated Supply ChainLocation: Ontario & Lupine Streets,Baton Rouge,Louisiana,70821-2830,United StatesExemptGlobal (ALL)

Honeywell is an equal opportunity employer. Qualified applicants will be considered without regard to age, race, creed, color, national origin, ancestry, marital status, affectional or sexual orientation, gender identity or expression, disability, nationality, sex, religion, or veteran status.