Benefits

• Be part of a supportive and stable working environment
• Working within a global team
• Has own car and licence

 
About the company
Work within a large global Biotechnology company that boasts a good company culture that is always expanding.
 
About the opportunity
The Senior Specialist for Site Inspections and Compliance is responsible for all activities involving quality assurance and compliance with applicable regulatory requirements; conducts audits and reviews/analyses data and documentation.
 
Duties

• Providing support for the preparation and execution of Self-Inspection to verify compliance with global GMP regulations and corporate requirements
• The identification and assessment of risks and facilitating appropriate mitigations to ensure compliance and continuous improvement
• Participate and support Regulatory inspections at the site, including providing responses to regulatory authorities in a timely manner
• Maintain processes, procedures, and SOPs for auditing and inspections to improve audit readiness
• Working with global colleagues to support the harmonization, maintenance and application of global audit strategy, processes, and SOPs to improve consistency across the manufacturing sites
• Maintain and share knowledge of Regulations and Guidelines by staying up to date with industry and regulatory trends to ensure compliance and continuous improvement
• Participate in local Quality Management Review and KPI preparation

 
Skills and Experience

• Bachelor's degree in science discipline, Advanced degree highly regarded
• Minimum of 3 years in quality or manufacturing experience in regulated industry, in the biotech or pharmaceutical industries
• Experience as an auditor, internal/external
• Knowledge and experience in sterile product manufacturing, biological processes, and laboratory operations
• Knowledge of global cGMP regulations and ISO standards
• Be an effective communicator, and able to prepare written an oral presentations
• Demonstrate the ability to understand data sets and drive to data-based decisions
• Possess excellent analytical and problem solving skills and use these skills to make sound decisions
• Be well organised and able to successfully manage deadlines
• Own car and licence is required for travel between sites

 
Culture
Although a large, global company, they are able to provide a family-like culture and prides itself in improving the lives of others.
 
How to Apply
Click apply or contact Jo Turner – Senior Specialist Manager on 03 9938 7120 for a confidential discussion.
 
About Healthcare Professionals Group
Healthcare Professionals Group recruits all positions: executive, permanent, contracting/temp, at all levels, across all areas of healthcare - Pharmaceuticals, Biotechnology, Medical Technology and Clinical Care.

• Medical Affairs & Life Sciences Recruitment - Clinical Research, Market Access, Medical Affairs, Pharmacovigilance, Quality, Data Management, Regulatory Affairs, Scientific
• Commercial Recruitment - Marketing, Sales, Analytics, Government and External Affairs
• Business Operations & Infrastructure Recruitment - Administration, Customer Service, Engineering, Finance, Human Resources, IT, L&D, Legal, Manufacturing, Operations, Supply Chain, Warehouse
• Clinical Care Recruitment - Allied Health, Aged Care, General Practice, Medical Imaging, Medical Management, Medical Specialties, Nursing

For more job opportunities, visit www.hpgconnect.com