Alvin Gibson Email & Phone Number

• Coordinated and directed Compendial Affairs Office merger integration processes, compendia databases, network directories, historical products and raw materials files, compendia library documentation within the new Pfizer Compendial Affairs Group.• Evaluated, analyzed software programs and assisted with the validation of automated systems for Compendial Affairs Office Quality Management Systems. • Administered and communicated official postings and correspondences of compendia information across the business units organizations utilizing Compendial Affairs Information Center [CAIC] website.• Reduced site assessments notifications from 4 weeks to 2 weeks with the implementation/distributions of eRoom Documentum Excel spreadsheets. • Coordinated global collaboration for 1,000 colleagues training including integration of new eRoom processes for 28 manufacturing sites. • Administered and enhanced strategic capabilities marketing domestic/international pharmacopoeia new compendia monographs submissions to Regulatory Life Cycle management teams.• Managed Compendial Affairs Office automated systems to increased ROI and efficiencies.• Streamlined processes to include automated systems resulting in reduction of headcount 5 to 1 staff.

Participating in a cooperative team work environment where senior professionals based in the Right Wilmington office assist and support each others’ efforts to conduct a productive career search. The networking team is accountable to provide insight, perspective, contacts and other reasonable support with the focus of assisting each member to be more effective in their job search.

• Wrote and compiled distribution for manufacturing compliance of Global Corporate Policies; conformance standards; division directives; corporate guidances and standard operating procedures (SOP)/job aids.• Managed the Quality System Elements (QSE) matrices planning phase for developing and revising all GMP-related documents for Subject Matter Experts (SMEs) approval.• Initiated global site change controls and facilitated pre-resolution/resolution meetings with network for official publication of documents into GMPharma Documentum Database.

• Researched and executed extraction of key CMC information from existing NDAs, ANDAs and AADAs for compilation of 35 CMC Indices and Correspondence Logs and preparation of 30 Supply Chain Site Regulatory Compliance Responses.

• Supervised and conducted 210% improvement cycle turnaround time drug dissolution stability metrics.• Conducted the calibrations for disso fill apparatus, UV-VIS spectrophotometers, analytical balances s and performance verifications of HPLC’s in compliance to ARDS Standard Operating Procedures.• Led Team drafting first SOP for Drug Dissolution Method Development and Validation Protocol.• Developed and analyzed drug substances, various liquid/solid dosage formulations for stability, potency, homogeneity and purity testing using automated chromatography systems HPLC, GC, TLC, UV-VIS and Phase Solubility Techniques.

• Executed and administered the distribution and proper documentation of controlled bulk drug substances/drug products, working standards, authentic substances in compliance to DEA regulations and regulatory requirements.• Spearheaded a computerized program for monitoring controlled substances called INVENT.• Directed and coordinated activities with IT&CS Group a more sophisticated vax-base SMART program, Clinical Supplies Inventory System (CSIS) improve the quality control manufacturing operations

• Wrote stability methodology, provided validation support for transfer of marketed products [Nubain Injection® (Nalbuphine Hydrochloride); Narcan Injection® (Naloxone Hydrochloride); Percodan® and Percocet® Tablets (Oxycodone Hydrochloride); Moricizine Hydrochloride® Tablets (Ethmozine Hydrochloride); Hycomine®; Hycodan® and Hycotuss® [Hydocodone Bitartrate] Syrups.• Research with senior chemists to introduce and implement HPLC valve-switching techniques within Analytical R&D to support parenteral formulations.