Quality Assurance Operational Manager
- To oversee quality and ensure a strong factory floor presence within the Manufacturing and Packaging areas
- To manage the CAPAs, Deviations, Audits and Vendor Quality Management Programs
- To promote quality culture across the site by liaising with cross functional teams
- To develop and manage the QA team and provide coaching and mentoring on Quality Management Systems
- To participate in internal and external audits, and support vendor quality management activities
- To conduct compliance risk assessments, trend analysis and provide recommendations for compliant business activities
- To focus on continuous improvement of processes. Update procedures and policies as needed to maintain compliance and improvement
- To establish, track and present Quality Metrics to support Quality Management Review
- To provide guidance for higher level decisions required for change management and deviation investigations
- To provide support and participate in internal and external, and other regulatory agency inspections (MHRA, FDA, EMA, etc.)
- To assist the QA with the planning of required internal annual audits and other audits as needed and assigned
- To conduct training and coaching of the QA team members on the how to conduct audits, documentation of findings, support for auditee development of audit action plans and evaluation of effectiveness checks as well as review/evaluate adequate completion of all planned actions via supporting documentation
- To supply feedback to the Head of Quality and SLT on any trends and serious quality issues or non-compliances that are detected by QA staff whilst carrying out duties for GMP and GDP activities
- To liaise with auditors to ensure that the CAPAs resulting from audits associated with the assigned programmes and studies are allocated a CAPA owner and closed out appropriately and in a timely manner
- To author, review and/or authorise Standard Operating Procedures (SOPs)
- To ensure adequate QA resources are available to deliver the agreed business targets
- To proactively influence management regarding the adoption of standards to improve quality, efficiency and compliance within Dechra
- Minimum of 3 years of experience in pharmaceutical industry with management experience 2 years
- Extensive experience in GMP manufacturing and compliance with demonstrated knowledge and experience of auditing/inspection techniques, including internal process/system and documentation audits, as well as experience of related quality assurance principles applicable to pharmaceutical manufacturing
- Competency in management and tracking of Quality Metrics- CCs, CAPAs, Deviations, Complaints, PQRs, audits and audit reports
- Previous people leadership experience preferred
- Previous experience working with MHRA, FDA and participating in regulatory agency inspections
- Previous experience of project management, time management and people management
- Demonstrates a "can do" approach
- Must have Excellent interpersonal and communication skills (written and verbal) across a wide range of disciplines, especially the ability to communicate diplomatically and work effectively in a multi-disciplinary team
- Excellent attention to detail, with the ability to work accurately in a busy and demanding environment
- Ability to multi-task, set priorities and meet strict deadlines
- Demonstrates time management skills
- Using logic and reasoning to identify solutions to problems
- Ability to lead, motivate, coach, and teach others
- First class organisational skills
- Ability to prioritise, demonstrating good time management skills
- Self-motivated, with the ability to work proactively using own initiative
Recommended Jobs
Sr. Security Cloud Architect
Req ID: 335887 NTT DATA strives to hire exceptional, innovative and passionate individuals who want to grow with us. If you want to be part of an inclusive, adaptable, and forward-thinking orga…
Marketing Coordinator
Make applying EASY....text MACO to (281) 688-6192 and start your resume! Join a great team and workplace! Founded in 1973, Texas First Bank is one of the fastest growing financial organizations in So…
2nd Shift Consolidator (4pm-12:30pm)
Job Title: Consolidator Location: 1805 Aviation Drive, Georgetown, TX 78628 United States of America Company Overview Coast to Coast Distribution is a membership-only retail warehouse, primarily…
Seasonal Landscape Technician
Job Summary: The Landscaper performs daily technical functions within the Landscaping department. This includes in-park work as well as maintaining the greenhouse operations. Essential Duties and …
Customer Relations Representative - State Farm Agent Team Member
Job Description Job Description Benefits: License Reimbursment Bonus based on performance Competitive salary Health insurance Opportunity for advancement Paid time off Traini…
*Sign-On Bonus* - General Dentist
General Dentist San Antonio, TX - Jefferson Dental & Orthodontics Jefferson Dental & Orthodontics is now hiring a Full Time General Dentist to join our Walzem Clinic! JDO is one of the faste…
Psychiatric Mental Health Nurse Practitioner in Longview, TX
Experience true work-life balance with on-site care and remote documentation. Join TeamHealth: Where your expertise meets compassionate care! We are seeking a psychiatric mental health nurse practiti…
QA Engineer Automated 3
Job Title: QA Engineer Automated 3 Location: Austin, TX Employment Type: Contract About Us: DMV IT Service LLC is a trusted IT consulting firm, established in 2020. We specializ…
Dentist
Dentist Location - McAllen, TX Position Summary: CHCP McAllen is looking for a Dentist to work in our dental clinic on campus. We are seeking a State of Texas Licensed Dentist to perform …
Ladies Shoes - Client Advisor
Neiman Marcus Group is a relationship business that leads with love in everything we do—for our customers, associates, brand partners, and communities. Our legacy of innovating and our culture of Belo…