Supervisor, Commissioning & Qualification

Date: Jan 19, 2023

Location: Miramar, FL, US, 33025

Company: Apotex

 

Aveva Drug Delivery Systems is a global leader offering a full range of research, development, and manufacturing capabilities to produce transdermal pharmaceutical products that can improve the quality of life, usage, and compliance rates for patients.

 

Job Summary

Under general direction, the Supervisor of Commissioning and Qualification (C&Q), will lead activities of the C&Q Group which includes, but not limited to: C&Q strategy development, protocol development, review, approval and as applicable, execution of engineering and qualification documentation such as commissioning, IQ, OQ, PQ, SAT, FAT, DOE, etc.  Likewise, the candidate will achieve and maintain required qualified state in accordance with different regulatory agencies and requirements for the different markets where our products are distributed. Also the candidate will assist or lead in the development of other documentation such as new equipment design and  documentation, PID’s, “as-built” drawings, user specifications, functional specifications, design and purchase specifications, change control, investigations, CAPA, Work Orders, and Document approvals

Job Responsibilities

  • Ensure all equipment, facilities, utilities and support systems, including new systemsQ are compliant with all regulatory, federal, state, local and corporate safety requirements
  • Lead and manage complex and technical projects, GMP activities and documentation required to ensure the achievement and or maintenance of the qualified state or state of GMP equipment, facilities and utilities including computerized aspects of such systems. This includes: user specifications, functional design specifications, installation and operation qualifications, SOP’s, safety inspection forms and procedures, etc.
  • When needed, represent the company to outside agencies and auditors for all Quality engineering related matters.
  • Review, create, and approve risk assessments for new and existing equipment and processes
  • Ensure C&Q strategies, practices and procedures are aligned with latest industry practices and guidelines.
  • Ensures compliance with all Company policies and procedures including safety rules and regulations.
  • Operates in accordance with our Code of Conduct and Business Ethics, and all established regulatory, compliance and safety requirements
  • Performs all work in support of our Values: Collaboration, Courage, Perseverance, and Passion
  • All other relevant duties as assigned.

 

Job Requirements

  • Education
    • BS/BA degree in science, engineering, manufacturing technology or closely related field.
  • Knowledge, Skills and Abilities
    • Knowledge of:
    • OSHA, FDA, Health Canada ISPE Guidelines, WHO Guidelines, international, state, and local regulations and guidelines.
    • Best practices in Commission, qualification, investigation practices and procedures.
    • Systems analysis, development and implementation principles and practices.
    • Management, supervision, administration, training practices and methods
    • Combination Product regulations - 21 CFR Part 211, 820 regulations
    • Skills in:
    • Analyzing and troubleshooting problems, identifying solutions, recommending and implementing methods, procedures and/or techniques for resolution.
    • Managing multiple projects, duties and assignments
    • Creating, planning and implementing goals, objectives and practices for effective, efficient and cost effective management of allocated resources
    • Communicating clearly and concisely, both orally and in writing.
    • Establishing and maintaining cooperative working relationships with others.
    • Proficient in applications such as Microsoft Word, Excel, Minitab, etc 
  • Experience
    • Minimum 8 years of experience in pharmaceutical industry of which at least 4 should be in commissioning and qualification activities.
    • Minimum 3 years of supervision experience
    • Experience in transdermal pharmaceutical manufacturing a plus

At Aveva Drug Delivery Systems, we are committed to fostering an inclusive, accessible work environment, where all employees feel valued, respected and supported. Aveva Drug Delivery Systems offers accommodation for applicants with disabilities as part of its recruitment process. If you are contacted to arrange for an interview or testing, please advise us if you require an accommodation.


Nearest Major Market: Fort Lauderdale
Nearest Secondary Market: Miami