Job Summary
This position is expected to work in partnership with and support manufacturing operations, technology transfer, quality control and assurance, engineering, and maintenance/facilities areas to solve problems, provide expertise and guidance on compliance issues and company quality policy requirements relating to critical systems. This position will, under guidance of the Manager, provide QA oversight to cross functional groups including but not limited to validation, engineering, and laboratory to ensure that activities and documents are accurate, complete, thorough, cGMP compliant and meet the requirements for the applicable various regulatory agencies and organizations.
The individual will have understanding and experience with systems related to Quality such as: Engineering, Chemistry, Microbiology, Manufacturing, Sterilization Assurance, Aseptic Manufacturing and Packaging / Inspection Operations. Under direction of the Manager, lead facilities and equipment quality system enhancement projects to increase regulatory inspection readiness. This position is in contact with FDA during inspections. This position reports directly to the QA Critical Systems Manager and does not have direct reports.
Responsibilities
PRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT
·Monitors and provides oversight for the validation and engineering programs to ensure that they are compliant with cGMP’s and that the site has a system for adequately evaluating the activities
·Perform periodic reviews of computerized systems per site procedures
·Reviews and approves changes to critical processes, facilities, equipment, and computer systems through the change control program
·As part of batch release, the individual will review, troubleshoot, and approve documentation related to critical systems and equipment (PMs/Calibrations, Change Controls, Pest Control, Facilities, Validation, EM, HEPA, etc)
·Provides quality oversight for software validation, equipment qualification and facility commissioning and validation. Prepares, executes, reviews and/or approves protocols, procedures and other necessary documentation
·Executes Gap Analysis and/or Risk Assessments to ensure evaluation of critical systems, computer systems and equipment are in compliance with all regulatory requirements, e.g., cGMPs, FDA regulations & guidance documents, PICS, ISO, PDA, ISPE etc.
·Develops and provides training to appropriate personnel related to facilities and equipment quality system to build quality awareness.
·Provides review and guidance for deviation reports related to critical systems
·Tracks and trends critical system data as appropriate
REQUIREMENTS
·BS degree with at least two years of experience in a Pharmaceutical manufacturing environment -or-AAS degree with a minimum of five years proven work experience – or- High School diploma with a minimum of 15 years proven work experience
·Must have excellent problem solving and communication skills. Writes and speaks fluently, clearly and concisely.Is effective and confident when communicating in a variety of settings both inside and outside of the organization.
·Demonstrates strong technical skills including good technical writing skills.Provides technical assistance to area supervisors or managers to solve complex problems.
·Remains calm and self-controlled under pressure.Builds good working teams.Develops effective and supportive relationships with colleagues.
Additional Information
We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company contribution, and wellness program.
Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.
