Emily Dickinson, Ms, Asq Cqa Email & Phone Number

Osaka, Jp

Saratoga Springs, New York, Us

Saratoga Springs, New York, Us

Mumbai, Maharashtra, In

Philadelphia, Pa, Us

• Oversee the stability lifecycle for all prescription and OTC products including DOE, feasibility, and pre-clinical through commercialization- Perform statistical analyses to support retest and expiration dating, hold times, and excursions- Ensure compliance with regulations for various regulatory bodies including FDA, MHRA, and DEA- Ensure laboratory and stability systems meet applicable data integrity compliance standards- Support customer and regulator audits and inspections• Provide stability oversight and support for regulatory submissions, laboratory and manufacturing investigations, capital and OpEx projects, product development activities and continuous improvement initiatives• Communicate project milestones to senior management, investors, and customers• Maintain favorable budget standing for all related projects• Drive professional and personal development of direct reports

Dublin, Ie

- Maintain an FDA / ICH compliant stability program- Ensure all stability studies conform to the applicable regulatory requirements for each development phase and through post-approval- Develop, initiate, maintain, and conclude stability studies- Batch identification, drafting of stability protocols and related documents, stability sample inventory management, on-going stability study maintenance- Maintain the Stability Laboratory Information Manager (SLIM) database- Disseminate stability data and statistical trends to project leads, business partners, and clients- Make recommendations for product storage conditions and/or shelf-life- Stability liaison with the Regulatory Affairs department - Assist with the drafting of CMC-related submissions for all drug products- Ensure capital projects meet all stability requirements- Participate in Audits and Inspections (internal and external) as the Stability Subject Matter Expert- Review and assess change controls for stability and/or regulatory impact- Schedule environmental chamber calibration and maintenanceExperience with stability program requirements for: - Parenteral dosage forms, Power and Liquid - Biologics - Solid Oral Dosage including DEA-controlled substances

-Routine analytical testing using both instrumental (GC, HPLC, DSC, UV/Vis, GPC, Particle Size, Karl Fisher) and general wet chemistry methods -Draft engineering studies, training protocols, standard operating procedures, and final reports-Train laboratory personnel on analytical methods and instrumentation

Master Of Science (Ms), Quality Assurance And Regulatory Affairs

Bachelor’S Degree, Chemistry