Job Description

This role is responsible to perform Quality Assurance Activities in accordance with current regulations and guidelines for Good Distribution Practice for Therapeutic Medicines and Medical Devices, Cosmetics, Food etc. under the Singapore Health Sciences Authority Regulations, PIC/S guidelines and applicable standards for global consumer goods. Ensures that the activities performed by IACs are maintained in compliance with applicable regulations (e.g. GxP, ISO, HACCP etc.), that appropriate licenses are held and that the integrity and safety of product are maintained throughout distribution through an effective Quality Management System. Responsible for the implementation and management of the overarching Quality Management System.Provide information and support across all areas of the business as required, including maintaining good working relationships.

Your responsibilities are but not limited to:

Records and Document Management

o Responsible for document control activities as well as implementation and maintenance of document management system

o Manage the Document Management System:

• Ensure records are completed for the activities performed.
• Support documentation and records are management throughout their life cycle.
• Ensure that due diligence and quality evaluation is performed as per Mundipharma procedures and policies

Management of Outsourced Activity

• Ensure Technical Agreements are in place to support MSHPL outsourced activities.
• Support Supplier management programme as required.

Quality Monitoring and Management Review (Complaints, Deviations, Recall, Change Controls, CAPA, Supplier Performance)

• Provide support to Ensure an effective Quality Management System within IAC, to be operated in line with current GDP requirements of PIC/S, local regulatory standards, and Mundipharma standards for all product classes.
• Continuous assessment of relevant quality / compliance / product risks and maintenance of quality systems to determine conformance to prescribed system and procedural requirements. Reports current risk assessment, findings and proposed system corrections to the appropriate functions as required
• Ensuring procedures and systems are in place to support activities of product handling and distribution for LAM in accordance with regulatory requirements and Mundipharma standards.
• Provide support to Complaint, Deviation, Recall, Change Controls, CAPA and Supplier Management Systems when required
• Ensure an effective CAPA system for recording of all actions for correction, prevention and improvement, with monitoring for closure in a timely manner.
• Support evaluation and approval of changes related to product, third parties, key business activities, artwork, etc. raised via a change control system.
• Provide support in investigation, tracking, trending and communication of complaints. Ensure escalation and notification in line with regulatory and Mundipharma standards and timelines.
• Support external inspections, complaints, recall, deviations, CAPA, incidents of counterfeiting and tampering, supplier performance and other relevant quality performance measures investigation, reporting, trending and communication to those required and management.
• Perform activities as defined in RACI Matrix.
• Support MP IT systems for the QMS (where applicable)
• Supports adherence to national legislation for any additional requirements imposed on certain products.
• Support continuous improvement initiatives.
• Other tasks as assigned by supervisor in line with business and regulatory requirements.

Audit Management

• Ensure internal audit programme is established, maintained and communicated. Actions identified should be tracked as CAPA. Schedule should reflect requirement for audit on at least an annual basis. Provide support for GDP certification and ensure it is attained and sustained as required Other tasks as assigned by supervisor in line with business and regulatory requirements.

Product and Market Release

• Support the final disposition of returned, rejected, recalled or falsified products as required

Training System

• Responsible for the development, implementation, and documentation of IAC cGMP and systems training
• Ensure initial and continuous training programme is implemented. Plans and records should reflect training activities.
• Provide Training as required and ensure records are completed for the training performed

IAC Support

• Support the compliance assessment of IACs\xe2\x80\x99 QMS.
• Support escalation of IACs\xe2\x80\x99 key issues to Line Management.
• Provide support in IACs\xe2\x80\x99 investigation and approval of investigations; evaluation and approval of change control where applicable
• Ensure reporting of all complaints in a timely manner to the complaints hub.

Qualifications and Skills

• Degree in Pharmacy, Chemistry or related discipline. Preferred Post graduate qualifications.
• A minimum of 5 years\xe2\x80\x99 experience in GxP or equivalent (e.g. Good Distribution Practice, Good Manufacturing Practice) for at least one of the preferred categories.
• A minimum 3 years being responsible for the operational management of a GDP/GMP Quality Management System
• GxP knowledge of therapeutic medicinal products, devices and controlled drugs (poisons), cosmetics biocides, foods, etc.
• Proficient in establishing and maintaining a GDP / GMP Quality Management System
• Experienced in Good Manufacturing Practice, drugs, devices, cosmetics, biocides, foods, etc
• Proficient in the use of Microsoft Office Applications.
• Audit experience of drugs, devices, cosmetics, etc.
• Competent in use of databases.
• Understanding of regulatory and supply chain
• Fluent in Spoken and Written English
• Fluent in other Asian Languages is a plus
• Exhibits Customer Focus in activities performed
• Demonstrates Integrity and ethical principles
• Shows Quality and Compliance Awareness in decision making
• Sets high standards for self and others
• Proactively leads self and others
• Works collaboratively maintaining good working relationships
• Clear communication engaging others to enable understanding

Additional :

Primary Location: SG Singapore

Job Posting Date: 2023-09-05

Job Type: Fixed Term Contract (Fixed Term)

Mundipharma