Sr Quality Assurance Specialist
The Sr. Quality Assurance Specialist is responsible for a variety of Quality activities ensure compliance with applicable quality objectives and regulatory requirements in the cGMP Quality organization.
So, what will you be doing? This role has a broad and varied remit and the successful candidate will have responsibility for duties including:
- Review batch-related documentation and ensure resolution of issues to ensure timely disposition of product. Communicate lot disposition pending issues to Management.
- Identify compliance risks and escalate the issues to appropriate levels of management for resolution.
- Gather quality metric information for use in continuous improvement of areas of responsibility.
- Generate, revise, and review standard operating procedures and other documents as needed.
- Review proposed changes to systems, procedures, and methods.
- Review validation-related documents, as needed.
- Perform quality review of manufacturing and laboratory investigations, GMP and Quality System issues, non-conforming materials, and CAPA, as needed.
- Investigate quality events by performing a thorough root cause analysis, plan science-based hypothesis testing, develop an effective Corrective and Preventive Action (CAPA) plan, and prepare a comprehensive report.
- Perform internal audits of GMP areas as scheduled, compile findings, communicate results and recommendations for improvement, collaborate with auditees to develop audit response and corrective action plans.
- Review test records, raw data, and documents according to company procedures, data integrity and adherence to specifications. Work with laboratory personnel to correct any errors and omissions in GMP documentation and promote a cGMP culture. Ability to pay attention to detail, focus and multitask on review of analytical laboratory data.
- Collect and analyze laboratory data for the monitoring and evaluation of trends.
- Author technical reports (i.e., environmental monitoring trending, annual product quality review), evaluate trends and escalate adverse trends to management.
- Perform evaluations of new and existing suppliers and service providers, maintain approved supplier list.
- Provide QA oversight of facilities, warehouse, production areas, and laboratories.
- Participate in regulatory inspections and client audits as required.
- Perform other duties as required to fulfill department and business needs.
Minimum Education: Bachelor’s degree in a Life Sciences or Chemistry discipline
Minimum of 5 years of relevant cGMP experience in the pharmaceutical/biotech industry
The Ideal Candidate
Here we pride ourselves on being an inclusive employer and we embrace candidates from all walks of life. We’re particularly keen to hear from those who have/are:
- Familiarity with Good Manufacturing Practices (cGMP's) and Good Laboratory Practices (GLP).
- Experience with manufacturing and laboratory investigations, deviations, and CAPA.
- Experience with change control practices and strategies.
- Experience with internal and external audits.
- Familiarity with Root Cause Analysis tools.
- Familiarity with risk-based thinking or risk-based tools.
- Knowledge of equipment, facility, and utility IQ/OQ/PQ.
- Familiarity with various analytical equipment, techniques, and methodology.
- Familiarity with microbiological test methods and environmental monitoring.
- Knowledge of current federal, local, and international regulations regarding the Testing, production and release of raw materials, drug substances and products. Excellent oral and written communication
- Experience with MS Programs such as Word, Excel, PowerPoint, Access, Project etc. and Proofreading skills
- Ability to manage multiple priorities and re-prioritize tasks as required. Excellent problem-solving skills
About the Company
For over 35 years, we’ve committed to serving the animal health community by providing products to extend the health span of companion animals and ensure a safe and abundant food supply. We believe every animal deserves proper care, that’s why we aim to create accessible and results-driven, quality products.
Dechra Pharmaceuticals PLC