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Sr QA Compliance Specialist

Date: Feb 16, 2021

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 overall regulatory and internal audit programming including; audit execution, reporting, and follow-up of internal GMP operations. As such, responsibilities include: conducting audits to ensure adequate application of GMP quality principals; GMP audit reporting; GMP audit corrective action recommendations and verification; and notification of discovered significant GMP deficiencies and subsequent corrective action updates to Senior Quality Management, Commercial Operations, Regulatory Affairs, and Supply Chain groups.  Responsible for ensuring compliance with US Drug Enforcement Agency and Florida Department of Business and Professional regulations.

 

 

Job Responsibilities

  • Perform internal audits of all areas identified in the internal audit schedule, and ad-hoc/for-cause audits as required, to assess compliance with site policies/procedures, regulations and Global Policies and Procedures.
  • Document audit observations in a detailed written report and provide compliance assessment for the area/system/process audited. Perform a risk classification of all observations and communicate any critical or major observations to senior management.
  • Conduct follow-up meetings with departments to ensure that internal audit observations are being addressed and that the agreed corrective and preventative actions are completed on time.
  • Maintenance of audit data and files for internal audits performed.
  • Oversee DEA compliance and reporting activities including maintaining registrations, security of controlled drug storage areas, inventory reporting, permits and quotas.
  • Oversee compliance with Florida Department of Business and Professional regulations including pedigree requirements, registration and licensing.
  • Provide support for Regulatory, Client, Internal and Corporate Audits
  • Develop and implement appropriate business processes and controls including SOPs, in order to maintain effective quality standards
  • Develop metrics and manage communication and tracking system to assure CAPA closure
  • Manage personnel in group, including: hiring/ disposition of personnel, conducting performance reviews and providing support for the development and management of relevant staff training/ development
  • Support business development process through due diligence and partner audits
  • Develop and maintain effective relationships with internal business unit and sites
  • Review and approval of audit trend reports
  • Manage the Supplier Qualification Program to ensure raw materials, intermediates, and products supplied to Apotex are of suitable quality for manufacturing processing and/or commercial distribution
  • Manage the supplier status review process to evaluate suitability of vendor and suppliers
  • Manage the supplier qualification

Relationship with Internal/External Customers & Stakeholders

  • Develop and maintain effective relationships with Clients, Affiliates as well as Operation Directors, and Supply Chain Group in order to ensure timely audits, communication, and resolutions to discovered GMP deficiencies and/or concerns

Problem Solving/ Analysis

  • Identifies root cause to complex and/or broader problems-develops solutions and implements action plans to mitigate risks, informing and escalating as required

Decision Making/Autonomy

  • Responsible for the operation of GMP Auditing including project planning and resource management
  • Make decisions and provides recommendations to senior management that have direct impact on quality and subsequent commercial manufacturing operations and/or product supply product
  • Evaluation of SME audit responses to ensure each observation  has been adequately approved

Drive For Results

  • Works with the Senior Management to ensure the continuous development and improvement of GMP Auditing operations    
  • Set department priorities/goals/metrics and assists direct reports in priority setting

Compliance & Due Diligence

  • Performs all work in accordance with all established regulatory and compliances and safety requirements
  • Provide technical and  regulatory guidance to internal and external stakeholders to ensure overall quality and compliance
  • Works as a member of a team to achieve all outcomes.

 

Job Requirements

  • B.S. in Chemistry, Biochemistry or a related science
  • Minimum 8-10 years of experience in the GMP Regulated industry, 2 years of which has been spent in the Quality Control Unit and 2 years in a management role
  • Thorough knowledge of GXP requirements
  • Clear and concise written and verbal English communication
  • Strong communication, interpersonal and organizational skills
  • Knowledge of excel, word, other Microsoft office programs

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