Pharmaceutical Manufacturing Operations Workstream Lead
Thanks for checking out our vacancy, we’re delighted you want to learn more about Dechra Pharmaceuticals PLC.
Dechra is a growing, global specialist within the world of veterinary pharmaceuticals. Our expertise is in the development, manufacture, marketing and sales of high quality products exclusively for veterinarians worldwide.
Here at Dechra, our values are embedded within our culture and thrive within our family of almost 2000 colleagues globally. From manufacturing to marketing, (D)edication, (E)njoyment, (C)ourage, (H)onesty, (R)elationships and (A)mbition are at the heart of our everyday operations and the way we do business.
Assist with the company’s Remediation Consent Decree and CMC programme(s) to ensure the improvement initiatives are delivered on time.
This Role supports Operations/Quality and reports to the Quality and Technical Operations Remediation Lead.
So, what will you be doing? This role has a broad and varied scope and the successful candidate will have responsibility for duties including:
- Assess and review current practices, advising on appropriate strategies to correct compliance gaps through intermediation controls and/or sustainable corrective/preventive actions.
- Working with regulatory affairs to understand, interpret on agreed CMC submission strategies/commitments for approved products.
- Building best practices, skills, and capability throughout the site organization, with the focus in the Operations, Engineering, and MS&T (Manufacturing, Science and Technology) functions.
- Apply pharmaceutical operational and quality knowledge to highlight inter-process, systems and capability relationships and related activities that require improvement.
- Working with Senior Management, conduct compliance risk assessments, trend analysis, provide and communicate recommendations for compliant business activities.
- Prepare and present project update reports to senior management as required.
The Ideal Candidate
Here at Dechra we pride ourselves on being an inclusive employer and we embrace candidates from all walks of life. We’re particularly excited to hear from those who have/are:
- Proven delivery of large to medium scale CMC and Consent Decree projects involving manufacturing, quality, supply chain and regulatory affairs in support of commercial products.
- Previous experiences working with FDA and participating in regulatory agency inspections.
- Extensive experience in quality, manufacturing, or MS&T departments of a commercial pharmaceutical manufacturing company.
- Experience and skill in Pharmaceutical industry, degree and/or +8 years of experience.
- Technical Experience in Validation, GMP/GLP Compliance, Pharmaceutical Engineering, Quality Assurance & Control, Regulatory Affairs, and Manufacturing Operations.
- Experience in Quality Management Systems, Quality Assurance and Compliance would be beneficial.
- Desired experiences in project management, change management, quality systems, quality assurance, validation, and manufacturing operations.
About the Company
As a people first values-based culture, we provide free weekly wellness sessions focused on our employee's physical and mental wellbeing, and flexible work arrangements. We offer a generous employer 401k match and an employee stock purchase plan for long-term financial wellness. Our full array of health, financial and voluntary benefit programs are what you would expect from a recognized Best Place to Work.
Dechra Pharmaceuticals PLC