Description
QUALIFICATIONS SUMMARY * cGMP quality management experience [ QA/QC and RA]. QA experience with quality management systems (QMS) and documentation, batch record reviews, annual product reviews, SOP drafting, review and approve, investigate deviation, change and document control. Established key performance indicators (KPIs), quality by design (QbD) process analytical technology (PAT) and Quality metrics. Experienced with deviations, out of specification (OOS) investigations and corrective action and preventive action (CAPA) implementations. * Conducted internal and external (CMO/CRO) auditits. Certified ISO 9000 internal Auditor and Regulatory Affairs Certified. Able to qualify vendors for APIs, raw materials and container/closures procurement. * Quality Control hands on experience with physicochemical techniques (HPLC, UPLC, LC/MS, GC, GC/MS, UV, FT-IR and GFAAS) and bioanalytical techniques (qPCR, SDS-PAGE, CE, ELISA and cell based assays). * Executed and managed analytical method validations and analytical technical transfers. Instrument qualifications (IQ/OQ/PQ) and full validations of analytical techniques for organic, inorganic and particulate analyses per ICH/FDA/USP/EP guidance. Extensive experience with implementation and execution of stability programs per ICH/FDA guidelines for small molecules and biologics. * Strong management experience of Quality Control and Quality Assurance groups. Able to train, lead and motivate direct reports of diverse educational and cultural backgrounds, towards prompt customer service and compliance resolution on a timely basis. Managed up to 20 scientists in cGMP facilities involved in tablet, capsule, parenteral, vaccine and topical formulations. Expertise using SAP, TrackWise and MasterControl QMS platforms. * Held position as Scientific Liaison which allowed me extensive interaction between USP, FDA, the pharmaceutical and biotechnology industries on regulatory, compliant and compential testing issues. * Ensured safety and environmental compliance to OSHA and EPA regulations. * Regulatory affairs experience with chemistry, manufacturing and controls (CMC) documentation. Investigational new drug (IND) using the electronic filing system, eCTD, for FDA submissions, post approval documentation and annual product reviews. * Able to draft technical documents using software such as Microsoft Word and publication software such as XML. Thorough knowledge of Excel spreadsheets and PowerPoint presentations. Able to deliver technical presentations to scientific and non-scientific audiences.
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