Management role with a Quality and/or R&D function in pharmaceutical industry, Expert knowledge of cGMP/GDP, EMA, & ICH requirements/guidelines, Experience working with R&D organizations, Familiarity with new product development lifecycle - including analytical method development, Solid influencing without authority skills, Experience in developing Quality Systems including CAPA, Deviations, and Change control systems, Ability to work independently while still meeting project goals, Strong problem resolution, judgment, and decision making skills, Proven Project Management Experience skills, Ability to Champion regulatory requirements and balance compliance with product requirements, Previous experience in due diligence and integrations activities an advantage, Previous experience working with external manufacturing organizations (CMOs) an advantage, ASQ certified Black Belt and/or Quality Engineer preferred, Executes (or supervises) the development and validation of analytical methods using multiple analytical techniques including CBPA, HPLC, qPCR, ELISAs, Western blots, protein content assays, etc. Download Pharmaceutical Resume Sample as Image file, Certified Pharmacy Technician Resume Sample, Pharmaceutical Sales Representative Resume Sample, Pharmaceutical Representative Resume Sample, Achieve contract performance goals and objectives for geographical assignment as established in the client agreement, Deliver product messages to prescribers and office personnel within established policies, procedures, standards, and workflows, Engage physicians in telephonic interactions and deliver product messages to prescribers within established policies, procedures, standards, and workflows, Develop superior product and disease state knowledge and effectively educate and engage healthcare professionals in telephonic dialogue, Foster ongoing trust with HCP/Physician, consumer or pharmacy as relationship develops to facilitate the decision making process, Develop superior product and disease state knowledge to effectively educate and engage healthcare professionals in two-way dialogue, Develop a daily/weekly call schedule to insure efficient and comprehensive coverage of territory, Provides back up to Account Manager in areas of reporting, coaching, mentoring and sharing of best practices, Candidate sourcing, recruiting and screening, Interview and assess internal & external candidates (phone screens and in-person) using behavioral, competency-based interviewing techniques, ‘Sell' candidates to hiring managers based on passive recruiting and/or phone interview results, Consistently consult and collaborate with hiring managers regarding expectations, challenges and strategies, Consistently consult with hiring managers regarding expectations, challenges and process improvements, Database Management; consistently reviewing pipeline for each requisition and dispositioning candidates accordingly, Maintain, clean and organize work area and participate in safety improvement projects, Maintain, clean, and organize work area and participate in safety improvement projects. This should include at least five years of Waters Empower (version 1 and/ or 2) support experience as well as five years of computer system validation, Must be very familiar with FDA and GMP regulations as applicable to the pharmaceutical industry, analytical laboratory practices and computer system validation methodologies, Experience with Waters Empower is required. Specific responsibilities include but are not limited to the following, Provide on floor support to ensure data integrity and compliance with sampling of raw materials and inspection of primary packaging components, Support regulatory audits Submit Work Orders to maintain compliance within sampling and component facilities Update Supplies Inspection protocols, logbooks, etc. developing and recommending alternative DW technical and data management solutions, methodologies, strategies and architectural improvement plans). Reviews any issues related to manufacturing performance, process and safety in order to ensure safety, compliance with regulations and cGMPs. HSE criteria, quality criteria, critical path milestones), Complete the scope of work to the satisfaction of the client and key stakeholders, while simultaneously ensuring that CH2M HILL’s HS&E, quality, financial, risk management, business and policy expectations are met, Play a role in the business development activities leading to the award of the contract. Specifically, this may require extra hours during busy periods, Must have 3 years minimum experience is a customer service role in the pharmaceutical sector, Requires clear diction and a good telephone manner and a commitment to excellent customer service, Manages and oversees the development of drug substances and drug formulations and/or transfer of development activities (including sterile products) with Shire contractors, Selects external Shire contractors as well as manages the day-to-day contractor activities, Monitors/supervises the manufacturing of drug products and drug substances (including sterile products) with Shire contractors, Writes/reviews protocols for manufacturing drug substances and drug products ( including sterile products), Writes CMC documents for registration purposes, including CTAs, IMPD, MAA, NDA and responds to agency questions, Provides any necessary support to line manager as required, Provides technical input for selecting external Shire contractors as well as managing the day-to-day contractor activities, Assists in the review and evaluation of CMC documents during a due diligence exercise, Uses DOE and QbD principles in developing robust API and Finished Product manufacturing processes, Bachelor’s degree from college or university in Chemistry, Chemical Engineering, Pharmacy or closely related field and at least 7+ years experience in the Pharmaceutical Industry, M.S. Follow up with all impacted groups, Serve as a liaison between FMS Finance offices and Corporate SAP IT Team to address any technical issues with the SAP Pharma distributor interface program, Maintain all pharmaceutical contract reporting and provide updates to FMS Finance and other key stakeholders to provide critical senior management reports to track the usage of all ESA and other key medications in use in the NA facilities, Work in collaboration with FMS Supply Chain to maintain and update all pharmaceutical purchase forecast models, Work in collaboration with FMS Corporate Accounting to monitor any pharmaceutical contract rebates earned to ensure accuracy and timeliness of all rebates paid by all contracted suppliers, Validate pharmaceutical sales reports released by national drug distributor against chargeback reports received by all FMCNA contract pharmaceutical supplier. Production Manager Resume Examples. Ensure information is accurate and up to date, Participate in new product/process transfers and validations. and product registration packages for local regulatory agencies, Facilitating meetings and otherwise maintaining relevant communication with local regulatory agency staff throughout the product approval process, Establishing timely updates and maintenance of global product listings, facility registrations, licenses, approvals and annual registrations, Investigating regulatory history of similar products to assess approval or registration implications, Collaborating the local teams to identify key regulatory requirements for projects and business initiatives, Assisting with the preparation of routine reports and regulatory agency communications; development, updating and maintenance of paper/electronic regulatory document archival systems; and, reviews of promotional/advertising or educational items, Identifying and addressing clientsâ€™ or managersâ€™ needs, including actively participating in client or management discussions and meetings; preparing concise, accurate project documents; and, communicating with clients in an organized and knowledgeable manner (e.g, Participating in practice development and thought leadership opportunities including, but not limited to client proposal development efforts, assisting with service/solution creation or enhancement, publishing industry whitepaper, and attendance at industry conferences, Minimum education BSc. Clean and maintain process equipment which may include, but not limited to tanks, filler, pumps, blenders, mills, presses, coating pans, etc, Assist with technical troubleshooting and preventive maintenance tasks as needed and trained. 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