Sr. Pharmaceutical Consultant

Company: Aerotek
Location: Raleigh
Posted on: April 9, 2021

Job Description:

Description: Understands project objectives, requirements, and assumptions necessary to structure a project or activity. Understands in-scope vs out-of-scope activities and communicates to project management for determination of need for scope change and additional funding requests. Works independently or on a team. Cultivates client relationships and builds trust through professionalism and expertise at the project level. Integrates into client environment in order to effectively execute projects while building positive professional relationships with clients and associates. Proactively seeks to expand PCI services. Identifies opportunities for new business and communicates these to management. Possesses basic organizational skills. Utilizes PCI Customer Account Folders to retain all project related documentation, plans, schedules, KPIs and reference documentation. Works closely with client project sponsors to research and identify efficiency gaps and compliance risks and provide effective long-term solutions. Mentors new hires and develops associates by sharing experience and expertise. Seeks internal and external training to broaden personal breadth of experience and expertise. Creates project-level Account Plans and develops a clear overview that includes the account service history, client goals; needs; objectives, site organizational structure, risks, escalation process and specific client guidance for project execution and deliverables with guidance from the Consultant II or Sr. Consultant. Organizes and participates in Business Review Meetings that includes input from all PCI Service teams and highlights additional areas where PCI can add value to the client's organization Experienced with project safety requirements and ensures team members comply with industry, client and PCI site safety requirements Actively participates in at least one professional organization (ISPE, PDA, NCSL, ASQ, etc.) to develop skills and maintain PCI's reputation as an industry leader by attending meetings, socials, technology shows and other active engagements.Skills:Validation, Commissioning, computer system validation, GAMP, CMMSTop Skills Details:CMMSComputer Systems Validation CommissioningAdditional Skills & Qualifications: Works directly with the Project Lead or Project Manager to ensure that projects stay on schedule, within budget, within scope and are meeting or exceeding the client expectations. Proficient with Microsoft Word, Excel, PowerPoint, Visio and Project Communicates with clients with a high degree of technical understanding. Analyzes business processes, diagnose inefficiencies, and conduct GAP analysis Develops simple process flow diagrams. Experience with System Impact and Component Level Criticality assessments Understands Calibration and Maintenance programs and FDA requirements for both including developing range, tolerance and test point requirements, developing maintenance work plans, performing safety critical assessments and identifying spare parts program requirements Familiar with Computer Validation System requirements and Computerized Maintenance and Calibration Management Systems (CMMS and CCMS) implementations Good writing skills. Able to develop SOPs, create final reports and author policies, procedures and guidelines under direct or indirect supervision. Working knowledge of and ability to apply GMP, GCP, GLP, GAMP and CFR21 Part 11 guidelines to ensure compliance as they relate to qualification of systems and validation of processesExperience & Education RequiredConsultant: A four-year degree in Life Sciences, or other related technical field, or equivalent military training, and six or more years of instrumentation experience in the Life Sciences industry. Familiarity with Quality Systems and the Life Science Manufacture Industry is required.Experience Level:Expert Level About Aerotek:We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Keywords: Aerotek, Raleigh , Sr. Pharmaceutical Consultant, Other , Raleigh, North Carolina