AI/MVI Inspection Manager

  • Company: Pfizer
  • Location: Kansas City, Missouri
  • Posted: April 10, 2017
  • Reference ID: 1051324

A career at Pfizer offers opportunity, ownership and impact. All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the biopharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives. The AI/MVI Inspection Manager will function as the site Subject Matter Expert for Manual Visual Inspection (MVI) and Automated Inspection (AI) process at the Pfizer St. Louis Site. This position will support both the Westport and Brentwood sites and will ensure robust MVI and AI programs are established and maintained for all Military and Commercial processes. The AI/MVI Inspection Manager will provide the necessary leadership to ensure the success of the MVI and AI programs at the site by establishing proper partnerships with Site Leadership, Operations, Engineering, Validation, Quality, Operational Excellence, etc. It is expected that the incumbent also have the skills and experience to clearly explain the MVI and AI programs to Regulatory agencies and ensure full compliance with cGMPs. This position will provide support for strategic site projects that will impact present and future regulatory compliance, reliability and efficiency of the site. He/she will be assist with planning and development of site capital projects associated with MVI or AI processes. The incumbent will establish new or refine existing processes and procedures for MVI and AI in accordance with cGMP practices, Pfizer PQS and CFR21 Part 11. This role will provide oversight of the Manual Inspection Qualifications of Inspectors and required Quality Assurance personnel to ensure all qualifications are performed within procedural requirements and in a consistent manner. He/she will work in a support role with the Product Technology group to provide oversight on the development, creation and qualification of Equipment Challenge kits and MVI Inspector Qualification test kits to ensure challenging of equipment and Inspector MVI qualifications are being performed correctly. Several key aspects crucial to the success of this position include: • Cross-functional team leader that can develop strategy and ensure execution across diverse stakeholder groups (Operations, Engineering, Validation, Quality, Product Technology, Operational Excellence, etc.) • SME of defect types and classifications for all Military and Commercial products, which includes raw glass, components, basic filled units and fully assembled auto-injectors. • Develops and maintains a cohesive regulatory inspection readiness program and serves as the SME for MVI and AI during regulatory agency inspections. • Ensures processes and procedures are aligned to Pfizer PQS requirements. • Ability to provide Senior Leadership level presentations for status, issue escalation and strategy alignment Bachelor degree plus minimum of 10 years of experience or Master degree in Science or Engineering with a minimum of 5 years of experience required. Technical Skills Requirements: • Candidate who possesses a Six Sigma Black Belt Certification and is well versed in Six Sigma Philosophies is strongly desired. • Strong background in Sterile Pharmaceutical Manufacturing (Aseptic Filling, Component Preparation, Container Closure), Quality Assurance / Quality Control, and Project Management. • Experience with Aseptic Sterile Container Closure configurations. • Background in Statistical Analytics is desired. Self-starter, team player with strong interpersonal and organizational skills. Excellent written skills in English. Good verbal communication and ability to coach and provide guidance to others. Computer literate, with skills in managing Excel spreadsheets (or similar database). Strong presentation skills. Proven record of problem solving, decision making skills and application of process improvement tools. Demonstrated skills in leading projects, managing and/or coordinating similar/related teams, units, work processes and/or functions. Comprehensive demonstrated skills in communicating (oral and written) effectively with diverse individuals/groups; facilitating trust, understanding, growth, empowering and enabling employee, business and customer relationships. PHYSICAL/MENTAL REQUIREMENTS This position requires: • Frequent standing, walking to access work areas. • Occasional bending, stooping, and lifting up to 25 pounds. • Wearing gowning and personal protective equipment in specific areas. NON-STANDARD WORK SCHEDULE, TRAVEL OR ENVIRONMENT REQUIREMENTS Position requires regular onsite attendance - this position cannot be performed on a remote or telecommute basis on a temporary, short or long term basis. Must have the ability to simultaneously multi-task across multiple capabilities and functions and handle multiple competing priorities and requirements, including performing site and functional responsibilities, responding to frequent e-mail and phone communications and attending multiple meetings and conference calls. These activities may not be time bound to core hours or presence at the site. Must have the ability to work effectively and manage to strict production, time and performance deadlines. Must be willing and able to work beyond the hours typically defined as a "regular" workday, which may or may not include weekends and holidays. Must have the ability to simultaneously multi-task across multiple capabilities and functions and handle multiple competing priorities and requirements, including performing site and functional responsibilities, responding to frequent e-mail and phone communications and attending multiple meetings and conference calls. These activities may not be time bound to core hours or presence at the site. Must have the ability to work effectively and manage to strict production, time and performance deadlines. Must be willing and able to work beyond the hours typically defined as a "regular" workday, which may or may not include weekends and holidays. EEO Statement EEO & Employment Eligibility Pfizer is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability or veteran status. Pfizer also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA. Pfizer is an E-Verify employer. This job is open only to Lawful Permanent Residents (as defined by 8 U.S.C. §1101(a)(20)), or Protected Individuals (as defined by 8 U.S.C. §1324b(a)(3), namely, U.S. Citizens, Refugees, and Asylees. Sunshine Act Pfizer reports payments and other transfers of value to health care providers as required by federal and state transparency laws and implementing regulations. These laws and regulations require Pfizer to provide government agencies with information such as a health care provider's name, address and the type of payments or other value received, generally for public disclosure. Subject to further legal review and statutory or regulatory clarification, which Pfizer intends to pursue, reimbursement of recruiting expenses for licensed physicians may constitute a reportable transfer of value under the federal transparency law commonly known as the Sunshine Act. Therefore, if you are a licensed physician who incurs recruiting expenses as a result of interviewing with Pfizer that we pay or reimburse, your name, address and the amount of payments made currently will be reported to the government. If you have questions regarding this matter, please do not hesitate to contact your Talent Acquisition representative. Additional Offer Details: Last Date to Apply for Job: March 31, 2018 Eligible for Relocation Package Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.

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