:Arranges, plans, manages and executes installations, operations and performance qualifications of packaging, laboratory and utility system
sSchedules, plans, manages and executes studies for cleaning validation
sSchedules, plans, manages, and executes process validation studies and authoring related plans, summary reports and protocol
sReviews and approves validation project documentatio
nCoordinates and interfaces with the process unit heads, quality and engineering groups to ensure successful project execution
sLeads and coordinates cross-functional teams for project validatio
nPriorities, manages and executes multiple projects utilizing the project management methodologie
sOversees external validation resource
sSupports the development of best and proven validation practices in the validation department based on current industry guidelines and practice
sAuthors relevant standard operating procedures for ensuring compliance with the company’s policie
sSupports regulatory submissions and also regulatory agency inspections whenever requeste
dChampions continuous improvements in the validation departmen
tKey Competencies (knowledge, skills and abilities every person must possess to be successful
)cGMP and Regulatory Compliance - Strong understanding of pharmaceutical cGMP, industry standards, and regulations to make sound regulatory interpretation, lead and/or conduct investigations, employ logic, and implement decisions from within the Quality Assurance organisatio
nProfessional Communication - Excellent verbal and written communication skills with the ability to interact across functions, departments, and seniority level
sComputer Literacy - Knowledge of and ability to use Microsoft Outlook, Excel, and Word, as well as other web-based system
sCollaboration - Utilize teamwork and problem solving skills across all departments and internally to Quality Assuranc
eProject Management - The ability to lead projects in relation to all quality functions including identify issues, initiate successful corrective actions, and completion of all tasks in timely manne
rEducation / Experienc
eBachelor’s degree or higher in relevant scientific/technical fiel
dTotal Combined Years: 4 or more years within industry or Regulatory/Compliance, including project management experience preferre
dExperience in project managemen
tMust be well organized with a keen attention to detai
lKnowledge of the various state and federal pharmaceutical validation laws and legislations that are enforced from time to tim