An international pharmaceutical and services company is advertising a vacancy for a QA Manager to be based in their office in Singapore. The organisation focuses on providing ethical access to medicines and delivering them through three areas of global medicine supplies: clinical trial, unlicensed, and licensed medicines. This is an exciting opportunity to with a global establishment and provide real expertise in the QA field.
- Evaluating and classifying all proposed changes affecting the Quality Management System.
- Taking a leading role in the Change Control Board meetings.
- Tracking the implementation of all changes against agreed Change Control Action Plans.
- Applying the principles of Quality Risk Management with respect to Premises, Equipment, Computerised Systems, Processes, Qualification, and Transportation.
- Identifying, assessing, controlling, communicating, and reviewing risks to the quality of medicinal products.
- Recording and classifying all deviations from written instructions, requirements of GDP and GMP, or an unexpected event.
- Investigating all deviations and record root cause, impact assessment, and trend analysis.
- Identifying corrective and preventive actions, as well as system improvements.
- Ensuring that corrective action is implemented in a compliant and timely manner.
- Creating, controlling, and maintaining documentation and formal systems to safeguard the Company's data records.
- Developing and maintaining the SOPs and other controlled documents.
- Ensuring Forms, Policies, and SOPs are kept up to date and are easily accessible by all staff.
- Developing and periodically reviewing the processes and documentation of the Quality Management System.
- Supplying quality documentation to partners and relevant government agencies.
- Providing training to relevant company employees in the Code of GDP, GMP, SOPs, and other necessary procedures.
- Maintaining training records.
- Participating in internal and external training as required, to ensure Quality Assurance practices are up to date and compliant with best practice and legislation requirements.
- Organising and performing internal compliance inspections.
- Ensuring all facilities are appropriately licensed and that the company personnel adhere to appropriate local regulations.
- Inspecting Packaging/labels/printed materials.
- Authorising the release of incoming stock after determination of compliance.
- Inspecting returned goods.
- Maintaining and reviewing complaints databases.
- Logging all entries and process responses, coordinating with Med Info and Customer Service if required.
- Segregating and reconciling rejected stock.
- Undertaking special projects and investigations as defined by the company.
- Ensuring that filing and documentation is up-to-date and is compliant with standard processes and formats.
- Completing required reports within designated timeframes.
- Participating in meetings as needed
- Liaising with management and staff to ensure projects are conducted efficiently.
- Communicating with staff & management using proper channels.
- Ensuring all authorised written procedures are followed accurately and report any deviations to the Compliance and Commercialisation Director.
- Assisting in identifying and solving compliance issues within the Company.
- Maintaining high standards of cleanliness, tidiness, and organisation of work areas.
- Ensuring that the facilities are appropriately licensed and that the company adheres to appropriate local regulations and company standards.
- Maintaining a current and comprehensive knowledge of relevant competitors and general products.
- Attending relevant industry conferences to expand knowledge of relevant therapeutic areas.
Skills and Requirements:
- Tertiary qualifications in Pharmacy, Science, or other Technical discipline.
- Demonstrable experience in Quality Assurance within the Pharmaceutical Wholesaling industry (at least 7 years preferred).
- Exposure to QA in an operational capacity.
- Demonstrable experience in secondary packaging processes.
- Significant experience of working within a GDP and GMP Quality Management Systems, with an understanding of facility design and operations.
- Experience in delivery staff training desirable.
- Auditing experience. Qualifications are highly desirable.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please contact Kelly Ko at +44 207 440 0639 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
Proclinical Staffing is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.
EA Licence No.: EA13C6865
Registration No: R1543631