Quality Assurance Manager

Description

Clinigen is a rapidly growing global specialty pharmaceutical and services company with a unique combination of businesses. Our divisions operate in a complex global regulatory environment and ensure that vital medicines are delivered securely on time and wherever they are needed in the world.

The Role:

We are looking for a dedicated and proactive Quality Assurance Manager to join our team. In this pivotal role, you will be responsible for ensuring the quality and compliance of our operations with GxP regulations, internal quality systems, and industry standards. You will work closely with cross-functional teams to implement and maintain quality management processes and continuously improve quality systems.

Key Responsibilities Include:

Change Control

• Evaluate and classify all proposed changes affecting the Quality Management System
• Lead role in the Change Control Board meetings
• Track the implementation of all changes against agreed Change Control Action Plans

Quality Risk Management

• Apply the principles of Quality Risk Management with respect to Premises, Equipment, Computerised Systems, Processes, Qualification and Transportation.
• Identification, assessment, control, communication and review of risks to the quality of medicinal products.

Investigation and Reporting Deviations

• Record and classify all deviations from written instructions, requirements of GQP and GMP or unexpected event.
• Investigate all deviations and record root cause, impact assessment and trend analysis
• Identify corrective and preventive actions, as well as system improvements
• Ensure corrective action is implemented in a compliant and timely manner

Document Control

• Create, control and maintain documentation and formal systems to safeguard the Company’s data records
• Develop and maintain the SOP’s and other controlled documents
• Ensure Forms, Policies and SOP’s are kept up to date and are easily accessible by all staff
• Develop and periodically review the processes and documentation of the Quality Management System
• Supplying quality documentation to partners and relevant government agencies
• The authorization of written procedures and other documents, including amendments and the retention of records

Training Activities

• Provide training to relevant company employees in the Code of GQP, GMP, SOP’s and other procedures
• Maintain training records
• Participate in internal & external training as required, to ensure Quality Assurance practices are up to date and compliant with best practice and legislation requirements
• Organize and perform internal compliance inspections.
• Ensure all facilities are appropriately licensed and the company personnel adhere to appropriate local regulations
• To ensure that the required initial and continuing training of his department personnel is carried out and adapted according to need.

Inspection

• Inspection of Packaging / labels / printed materials
• Authorise release of incoming stock after determination of compliance
• Inspection of returned goods
• Maintain and review complaints database
• Log all entries and process responses, coordinating with Med Info and Customer Service if required
• Customer complaints & returns
• Segregation and reconciliation of rejected stock
• The inspection, investigation, and taking of samples, in order to monitor factors which may affect product
• quality
• To ensure that all necessary testing is carried out and the associated records evaluated
• To approve specifications, sampling instructions, test methods and other Quality Control procedures

Validation

• To ensure that the appropriate validations are done
• To ensure the qualification and maintenance of his/her department, premises and equipment;

Suppliers

• The approval and monitoring of suppliers of materials
• The approval and monitoring of contract manufacturers and providers of other GMP related outsourced activities

Administration

• Undertake special projects and investigations as defined by the company
• Ensure filing and documentation is up-to-date and is compliant with standard processes and formats
• Complete required reports within designated timeframes
• Participate in meetings as needed
• Liaise with management and staff to ensure projects are conducted efficiently
• Communicate with staff & management using proper channels
• Master computer skills and required software programs

Knowledge and Compliance

• Ensure all authorized written procedures are followed accurately and report any deviations to the Quality Assurance Manager
• Assist in identifying and solving compliance issues within the Company
• Carry out your duties in compliance with GQP and GMP requirements
• Maintain high standards of cleanliness, tidiness and organization of work areas
• Ensure the facilities are appropriately licensed and the company adheres to appropriate local regulations and company standards
• Maintain a current and comprehensive knowledge of relevant competitors and general products
• Attend relevant industry conferences to expand knowledge of relevant therapeutic areas
• Understand the issues affecting the customers who prescribe our products and patients who use them
• Promptly notify Clinigen’s pharmacovigilance unit of all adverse reactions reported
• Maintains up-to-date knowledge of industry trends, cutting-edge practices and techniques, current publications, regulations, etc.
• Maintain up-to-date knowledge of Clinigen’s standard operating procedures and policies and ensure compliance at all times
• Contributes to a Quality-focused mindset; Quality is everyone’s responsibility.
• Ensure every team member has the opportunity to work in a safe and health work environment.
• Ensure your Company related activities comply with relevant Acts, legal demands and ethical standards

Requirements

• Japanese (Native)/English (Business)
• Demonstrated experience in Quality Assurance within the pharmaceutical industry (7+ years preferred)
• Exposure to QA in an operational capacity
• Demonstrated experience in secondary packaging processes
• Significant experience of working within a GQP and GMP Quality Management Systems, with understanding of facility design and operations.
• Demonstrated experience with Auditing and qualifications are highly desirable
• Comfortable in a fast-paced environment with minimal direction and able to adjust workload based upon changing priorities.

If you are passionate about quality assurance and looking for an opportunity to make a meaningful impact in a growing organization, we encourage you to apply today.