Sr. Pharmaceutical Consultant
Company: Aerotek
Location: Raleigh
Posted on: April 9, 2021
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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
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