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QA QC Director - Aseptic

Job Introduction

Dechra is an international specialist veterinary pharmaceuticals products business. Our expertise is in the development, manufacture, and sales & marketing of high-quality products exclusively for veterinarians worldwide.

The Director of Quality Assurance and Quality Control will assume the responsibility for Quality oversight and Laboratory operations. This individual is the primary QA/QC point of contact for new product introductions, non-conformance investigations, process/facility changes, and corrective actions for one or more areas of operation. This individual will play an integral role within a cross-functional leadership team that includes Manufacturing, MS&T, Analytical Sciences, Quality Control, Supply Chain, and Regulatory Affairs.

Role Responsibility

The Director of Quality Assurance and Quality Control is responsible of serving as a cGMP contact for the leadership team, this position has designated owner and approver responsibilities that may include but are not limited to:

 

  • Document Control
  • Change Control
  • Investigations, Deviations; Out of Specification
  • SOP Revisions
  • Risk Management
  • CAPA (Corrective Actions / Preventative Actions)
  • Operating and Aseptic Manufacturing Procedures
  • QC Laboratory Procedures and Methods
  • Audit liaison and commitment tracking / closure
  • Project team participation and leadership
  • Product disposition
  • Equipment and System Validation
  • Develop capital and expense budgets for QC Operations, underpinned by an effective capacity planning tool and continuous KPI measurements, and operate within the approved budgets.
  • Understands timelines and demonstrates a sense of urgency and responsiveness
  • Oversee QA/QC aspects of API, Aseptic Drug Product and Packaging and Labelling Operations
  • Compile metrics of Batch Disposition, deviations, CAPAs, as applicable.
  • Establish and direct QC Laboratory in QC support activities for GMP manufacture that will include method transfer, in-process testing, analytical method validation, Drug Substance (DS) and Drug Product (DP) release testing, DS and DP stability studies, reference standard qualification, etc. utilizing HPLC, GC, FTIR, Atomic absorption, KF and UV-vis.
  • Provide operational and strategic leadership and management to the QC Chemistry laboratory functions in their application of testing standards to ensure a fully compliant, effective, and safe QC Operation
  • Oversee implementation and maintenance of QC functional group standards, instruments, methods, cGMP documents, sample handling, and applicable electronic systems (including LIMs).

Additional responsibilities include management and evaluation of compliance issues/regulations, ensuring progress against commitments to regulatory agencies, identify compliance gaps and lead focused teams to resolve compliance issues, provide written compliance assessments to management on request, and interpret regulations.

The Ideal Candidate

  • Demonstrates knowledge of current Good Manufacturing Practices (GMPs) and/or Good Laboratory Practices (GLPs) and documentation standards.
  • Demonstrates basic knowledge of FDA standards and quality system.
  • Demonstrates good verbal, written, and interpersonal communication skills are required.
  • Demonstrates working knowledge in Microsoft Office applications
  • Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR, and cGMP regulations.
  • Demonstrates working knowledge of QC laboratory equipment; HPLC, GC, FTIR, UV-vis, KF, etc.

 

Adhering to Principles & Values

Working with People

Applying Expertise & Technology

Writing & Reporting

Following Instructions & Procedures

Analysing

 

  • Bachelor’s degree in Chemistry, or any other scientific discipline.
  • Solid and relevant experience in a GMP environment that constitutes Drug Substance, Drug Product, and Packaging and Labelling.
  • Working knowledge of cGMP, quality systems and regulatory requirements (21 CRF Part 11/210/211) practices/principles

Dechra Pharmaceuticals PLC

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