pharmaceutical gmp resume

Order pharmaceuticals and supplies for the pharmacy, Maintain all backorder information. Procurement responsibilities include providing information, guidelines and collaboration to facilitate the procurement process. Receives assignments in the form of objectives and determines how to use resources to meet schedules and goals, Program or project responsibility generally within the function. Propose and provide input for the design of next experiments, Optimize existing methods (lab or plant) and develop more efficient ones, Generate lab procedures, reports and/or instructions and/or SOP’s, Actively transfer procedures/instructions to pilot plant or production, including troubleshooting, process steering controls etc, Communicate and address problems, perform safety and literature searches under moderate guidance from more experienced team member, Keep record of and manage chemicals, intermediates, excipients and solvents within own area of responsibility, Collaborate with other team members to facilitate deliveries of DS and/or DP, Utilize special tools/equipments and/or specialized facilities e.g., containment/sterile labs, Contribute to maintenance of infrastructure/equipment, Actively participate in project teams/meetings/networks, Ensure all own activities are aligned with overall drug development process, Work according to appropriate SOPs, GMP, GLP, QM, HSE, ISEC & Novartis Guidelines, Minimum of 3 successful years of experience in industrial setting as associate scientist (promotional pathway) or 3-5 years (for BS) or 1-3 years (for MS), Awareness/proven experience for safe handling of chemicals, potentially dangerous materials and equipment, Proven scientific and technical knowledge and experience (in industrial setting) in the area of capsule filling (preferably with dosator-, tamping pin- and drum- filling technology), Good mechanical understanding / proven track record in innovating/improving equipment setup (lab / pilot plant) (experience in CAD models pre-ferred), Adequate knowledge in scientific/technical areas of collaboration, Proficient with laboratory and/or technical tools, Adequate knowledge of software and computer tools, Actively participate in teams, projects, networks and/or platforms. standardization, transformation, rationalization, linking and matching that leverages data standards, processes and technology management for data, master data, and metadata; and, data security (including data masking and related data protection techniques), Identification and addressing of client needs--developing and sustaining deep client relationships using networking, negotiation and persuasion skills to identify and sell potential new service opportunities; preparing and presenting complex written and verbal materials; and defining resource requirements, project workflow, budgets, billing and collection, Team leadership--generating a vision, establishing direction and motivating members, creating an atmosphere of trust, leveraging diverse views, coaching staff, and encouraging improvement and innovation, Global trends in market access and requirements for launch management, Key market requirements regarding access strategy, pricing and reimbursement, especially in the context of product launch or lifecycle management, Pricing and profitability strategy, price setting, and innovative contracting, Contracting and rebate modelling for the US market, Target product profile development, unmet market needs, clinical end points to support pricing and market access strategy, country launch sequencing, and other pricing and market access factors, Budget impact modeling, including pharmacy and medical claims analyses. 2015. three years of successfully demonstrated directly related experience in drug product development or manufacturing process development in pharmaceutical industry, Proven track record in the development of innovative solutions for drug product manufacturing, e.g. Ein G… Deliver accurate and timely follow-up discussions with HCP’s and office staff. download Pharmaceutical Industry Resumes in pdf,doc,zip formats.visit for more Pharmaceutical Industry Resumes to download in pdf,doc,zip formats. Ability to communicate internally and externally with impact, Excellence in being self-driven and organized, Team Player capabilities within an international (global) team, Language: English required, either German or French at high proficiency level, Italian or Spanish would be an asset, Demonstrate good interpersonal, communication, and presentation skills, Sucessfully handle multiple projects to achieve company objectives, Exhibit competency in use of common computer software packages, Demonstrate ability to work within a project plan, Must have a four-year degree in chemistry, chemical engineering, pharmacy, or related discipline, Students pursuing master or Ph.D. degree preferred, Degree focus on pharmaceutical technology relating to oral dosage forms preferred, PhD or MsC in pharmaceutical technology, pharmaceutics preferably, 10 years or more of experience in product formulation development, especially small molecules (solid dosage form is a must have. Evaluates participation impact and reassesses objectives and outcomes; plans for continuous improvement. Only 1 left in stock (more on the way). Efficiently partner with other departments locally and globally, Develop and implement short, mid, and long term strategies to ensure scientific excellence, state-of-the-art technologies, and regulatory compliance. ), Experience in CBPA, qPCR and other routine analytical methods including SDS-PAGE, Western Blotting, UV, Bioburden, etc, Excellent instrument skills including HPLC equipment, columns, and associated computers and detection systems, including troubleshooting/problem solving, Proficiency in use of HPLC (Empower, ChemStation, etc. A good knowledge of cGMP and regulatory requirements, Relating to the pharmaceutical industry is required, The position requires a moderate level of manual work, in the movement, charging, And discharging of raw materials and finished products. Evaluated by World Education Services (W.E.S. ), Assure that employee grievances are heard and resolved (with help from appropriate support employees, as required) and that personnel records are updated and accurate (Change of Status forms, rosters, etc. Coordinates with creative team to produce program materials. Develop and execute plans to maximize selling resources, Report and monitor sample and literature use, and maintain accurate records, Distribute product samples in accordance with approved sampling guidelines and marketing literature to physicians and other healthcare providers (HCP’s), Collaborate with partners on routing and resource utilization to maximize overall footprint performance, Provide feedback to District Managers on market place trends, challenges, programs, response to promotion, and product access. Retrieves components and equipment from aseptic storage, Assists with Isolator and room cleaning in production areas. The adequacy of any procedures is subject to the interpretation of the auditor. Acts as an advisor to subordinate(s) to meet schedules and/or resolve technical problems. or similar function, Leadership, demonstrated through the ability to lead projects and willingness to work successfully with diverse team members, while establishing and delivering goals in a team or independent work environment, Integrity, supported by a proven record of delivering results by fostering open communication, effectively preparing written communication and speaking/presenting openly and honestly, Flexibility, evidenced in the ability to partner effectively and achieve results through influencing team members and agency partners, while understanding and incorporating customer needs in the decision making process, Efficiency, exhibited through strong financial and analytical skills with the ability to make recommendations based on in-depth quantitative analyses, sound problem-solving and decision-making skills with demonstrated ability to identify key issues, consider customer needs, make well-support fact- based recommendations, and identify and implement appropriate actions within specific deadlines, Previous experience in the Healthcare industry, Providing strong R&D functional knowledge and expertise to team members, Providing solutions to complex business problems within an area of responsibility, where analysis of situations and/ or data requires in-depth R&D industry knowledge and an understanding of an organization’s objectives, Leading teams (managers, consultants, analysts) on client engagements, with accountability for (1) correct focus and alignment to client expectations, (2) on-time completion of the work, and (3) a work product meeting or exceeding the highest quality standards, Using research and professional experience to develop innovative thought leadership and points of view and to contribute relevant industry insights to project teams and clients, Leading teams in the design, development and implementation of business operating models, (e.g., vision and strategy, business processes, organizational and governance structures, supporting tools and templates, performance metrics), and the related change management activities associated with implementation, Defining the strategic direction of a project team aligned to client interests and expectations, working with the team manager to communicate and execute that strategic direction effectively within the project team, Interacting with senior management at a client and/ or within Accenture, which may involve negotiating or influencing on matters of significant importance, Using latitude in decision making and judgment to determine solutions to day-to-day and project challenges, Managing large teams and/ or work efforts (if in an individual contributor role) at a client or within Accenture, Contributing to the growth of the R&D Consulting Practice by identifying and pursuing new business opportunities, leading proposals, presentations, recruiting activities, and by coaching and mentoring managers, consultants, analysts, 7 + years of consulting experience with an emphasis in management consulting, 7 + years of experience working in the Life Sciences industry, Bachelor’s degree; science or engineering degree preferred, 4+ years working in Life Sciences R&D industry (e.g., clinical development, pharmacovigilance, regulatory, medical affairs), or related areas (e.g., CROs), Evidence of strategic consulting experience, including but not limited to, Building and sustaining long-term client relationships, Selling and delivering an expanded range of management and technology consulting services, Assess and improve regulatory affairs and regulatory operations processes and their underlying technology platforms, Provide regulatory information management subject matter expertise in areas such as document management, requirements management, submission planning and tracking, submission publishing, and registration and commitment tracking, Typical projects consist of definition of a regulatory IT roadmap, assessment of current regulatory technology footprint and/ or design and implementation of regulatory systems to achieve a desired future state, Other projects may involve the design, development and implementation of regulatory operating models, including vision and strategy, business processes, organizational and governance structures, supporting tools and templates, and performance metrics, along with change management to support these efforts, 4+ years of regulatory consulting experience in an IT/systems development environment, Ability to meet travel requirements: depending on your location and specific project responsibilities, this position may require up to 75% travel (Monday – Thursday), Proven ability to work creatively and analytically in a problem-solving environment, Understanding of key Pharmaceutical R&D processes and technologies. Preference for Dutch speaking skills, Willingness to travel on a regular base internationally (15%), Quality Assurance responsibilities include but are not limited to cGMP documentation review related to product release, facilities and equipment, material controls, laboratory controls, packaging and labeling, and production & process controls, Establish and report metrics related products and processes as deemed necessary by the RQM, Ensure the site manufactures products to meet the requirements of 21 CFR 212 (CGMP), Responsible for the quality of documentation (control, retention, and archival) to support CGMP activities, Engage and collaboration with operations department to drive quality system and CGMP requirements, Responsible for product release activities per CGMP requirements, Responsible for reporting quality system issues to the regional RQM. GMP Pharmaceuticals 25th Year Anniversary and Opening of Headquarters. Supervise the technical set up and technical personnel's activities for the Filling, Capping, Participating in pre-FAT testing for new production equipment. Combination type RX/medical devices, drug releasing implants and topical drug delivery patches, Mathematical and statistical computation methods andtechniques, Administration, supervision and training practices and methods, Recruiting, interviewing and selecting applicants in accordance with established employment practices and methods, Current Company policies, practices and procedures, including safety rules and regulations, Responding to complex inquiries frommanagement, employees and regulatory agencies, Communicating clearly and concisely, both orally and in writing, Managing multiple projects, duties and assignments, Establishingand maintaining cooperative working relationships with others, Creation and maintenance of the Pharma/Dialyzer annual audit schedule and corresponding audit plans based on input provided from management, Create and implement a monitoring program that identifies KPIs for key QSR activities and reports these metrics to management, Ensure adherence to Corporate QS Compliance SOPs and Policies and assuring they are accurate, up-to-date and reflect current practice and reports on ineffective procedures, policy exceptions, reporting discrepancies and evaluates corrective actions and regulatory commitments, Represent the Corporate QS and Clinical Compliance group at meetings, Leads the collection, organization and dissemination of quality knowledge and training about the company, its products, and skills that enable associates to perform their jobs in a continuous state of compliance with applicable regulatory requirements, Tracking of metrics related to audit execution, tracking and closure, Perform audits according to audit schedule and coordinate scheduling of QS and Clinical Compliance activities, Based on results internal process audits, collaborate with Technical Operations, Quality Systems, and GMP Quality functions to identify CAPAs and manage and approve their completion, Contribute to the Quality Management Review, Assist/participate in inspections of FMCNA by Regulatory Authorities, Provide inspection readiness activities throughout the organization including training colleagues across Pharmaceutical organizations on regulatory interactions, Develop internal auditor training program, Interface with internal colleagues, industry leaders and regulatory experts to align audit requirements for FMNCA and provide clarity to the organization of the going-forward support model, as required, Evaluates resource allocations, manages resource and capacity analyses, and oversees the training requirements for direct reports, Participates in continuous improvement efforts to streamline compliance and simplify procedural and other requirements to ensure ease of following system requirements, Provides leadership and coaching to all direct reports and partners with human resources on employee matters, Manage the tactical execution of short- and long-term objectives through the coordination of activities with a direct responsibility for results, including costs, methods, and staffing, Technically proficient in the specific department and knowledge of industry practice and business principles. 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