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Cleaning Validation Lead

Date: Jan 12, 2022

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

Responsible for the preparation and execution of validation protocols and reports according to Good Manufacturing Practices and established Standard Operating Procedures. This includes responsibility for work scheduling and prioritization, as well as identifying and correcting potential roadblocks.

Job Responsibilities

  • Follows and ensures all cGMP’s, SOP’s, Health and Safety, and company policies/regulations and remains aligned to the Apotex Strategic Objectives.
  • Oversee the cleaning validation program by:
    • Ensuring that all protocols and reports are executed and approved in accordance with the department work schedule and guidelines
    • Ensuring that all validation work is staffed and supported properly in order to ensure the customers deadlines are met
    • Providing guidance and support for problem identification and resolution with protocols, reports or qualification studies
    • Communicating and prioritizing projects with customers when conflicts or work scheduling issues arise
    • Following up with her/his supervisor to ensure all protocols and reports are reviewed in a timely manner.
  • Ensure that all work is performed in full compliance with Good Manufacturing Practices, Standard Operating Procedures, established safety standards and regulatory requirements.
  • Review and assess impact of changes to the validation status, using the established change control procedures.
  • Act as the main department liaison for the status of validation projects.
  • Where applicable, In conjunction with the Technical Operations leader, ensure each role in the department has a training plan reflective of the job, and ensure both new and existing employees follow this training program.
  • Take responsibility for the cross-training of Tech Ops staff to better support cleaning validation program.
  • Ensure vacation requests does not compromise consistent service levels required for the business.
  • Serve as the Cleaning Validation Subject Matter Expert during inspections by regulatory agencies.
  • In conjunction with the Technical Operations leader, ensure that all department-specific costs are monitored and aligned to the budget.
  • Assume certain responsibilities of the Technical Operations leader in their absence.
  • Performs all work in accordance with all established regulatory and compliance and safety requirements
  • Utilize open, honest, two way communication to build trust-based relationships with peers, business partners and direct leader while continuously improving leadership capabilities by personally seeking feedback and development
  • 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

  • Bachelor Science or Bachelor Engineer or related science

Knowledge, Skills and Abilities

  • Demonstrated experience in leading and motivating teams within a fast-paced environment towards common goal(s).
  • Excellent oral and written communications.
  • Strong interpersonal skills.
  • Proven organizational, time management, and people management skills.
  • Ability to work independently with minimal supervision.
  • Strong customer service orientation.
  • Experience in transdermal dosage, liquid dosage technology, with an understanding of ICH, Health Canada, FDA, EU and other applicable regulatory guidelines is an asset.
  • Intermediate to advanced computer skills in MS Excel and Word. Familiarity with LabWare LIMS, LiveLink/Content Server, SAP, and TrackWise is an asset

 Experience

  • Minimum of 5 years in pharmaceutical industry
  • Minimum 3 years in a validation role.

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