QA Packaging Compliance Lead

QA Packaging Compliance Lead

The QA Packaging Compliance Lead, reporting to the QA Packaging Manager, responsible for ensuring that all activities related to the investigation and resolution of non-conformities are performed on a timely manner and in compliance with company and regulatory requirements.

• Strong knowledge and understanding of regulations and guidelines in packaging processes and QA inspection activities in packaging
• Strong knowledge and understanding of Data Integrity requirements
• Strong Technical writing skills, problem solving, and analytical thinking are essential to the role.

RESPONSIBILITIES

Communication:

• To provide daily report on QA performance information as required
• To communicate quality metrics information where applicable
• To attend packaging tier meetings and provide information on investigations progress as assigned by the QA Packaging Manager
• Ensure regular Quality interaction with other Departments

Main activities:

• Proficiently lead and actively participate in the investigation of Deviations/Non-Conformances/Technical Complaints to ensure investigations are completed in a timely manner and high-quality standards
• Effectively and efficiently write Deviations/Non-Conformances investigation reports
• Responsible for reviews and evaluations for completeness and compliance of the investigation reports and CAPA plans authored by Subject Matter Experts (SMEs) and other company personnel
• Responsible for delivering training related to CAPA, Root cause analysis and quality investigations to company employees
• Efficiently follow up and verifies that corrective / preventive actions are appropriate, are implemented as planned and have the intended effectiveness in the QA Packaging Department
• Participate/Lead investigations due to quality issues that could range from errors in production, incomplete batch records, component reconciliation, poor documentation practices, etc.
• To Lead Quality risk assessment related to the area
• Responsible for developing and improving SOP's
• Responsible for periodic reviews and updates of QA Packaging SOPs
• Participate and action change controls tasks assigned to the QA Packaging Department
• Responsible for participating in the internal audit program
• Lead Process/product/system improvement projects in the QA Packaging
• Training of new QA Packaging personnel
• GMP implementation and site-wide Quality Awareness related to Packaging process
• Lead audit readiness process for Packaging and QA packaging
• Participate in various inspections e.g. HPRA, FDA, customers, etc.
• Liaise with other Department representatives to promote improvements in GMP and Quality standards
• Any additional tasks as assigned by the QA Packaging Manager or Technical Director

REQUIREMENTS

• 5 years of extensive experience in a quality or manufacturing setting or similar role
• Strong Technical writing skills
• Competence in Microsoft packages specifically word, excel and PowerPoint and in SAP
• Ability to handle multiple projects/tasks and deadlines
• Proficiency in communicating and collaborating at all levels of the organisation
• Demonstrated problem solving skills and analytical approach
• Demonstrated project management skills
• Strong Decision-Making skills
• Sc. or equivalent in chemistry, biochemistry, pharmaceutical science, or related field
• Knowledge of Quality Risk Management tools an advantage
• Certification in Project Management disciplines an advantage
• Certification in Problem solving techniques an advantage