Lifescience Healthcare

Overview

PSA International is a leading port group and trusted partner to cargo stakeholders. PSA actively collaborates with its customers and partners to deliver world-class port services alongside, develop innovative cargo solutions and co-create an Internet of Logistics. PSA BDP focuses on supporting cargo owners to ensure their supply chain is resilient, agile, sustainable, and cost efficient. We operate a global network of digital solutions to remove complexity for our customers and create long-lasting relationships built on trust.

We are seeking a highly capable LSH Quality Assurance Manager to ensure strong quality governance for a key Life Sciences & Healthcare customer in Singapore. This position is responsible for ensuring quality excellence, compliance with industry regulations, delivering customer satisfaction, and assesses and addresses risks associated with storage and distribution of lifescience and healthcare products. The role will also serve as the single point of contact (POC) for both internal teams and the customer, driving collaboration and continuous improvement.

Key Responsibilities Regulatory and Certification Compliance

• Manage the application and maintenance of licenses for the importation, wholesale and distribution of lifescicence and healthcare products, including controlled drugs.
• Act as the responsible person (RP) for implementing and maintaining an effective quality management system that meets GDP Standard and ISO13485
• Coordinate with clients and relevant functions for timely FSCA (Field safety corrective action) reporting to local health authority.

Governance of Quality Documents and Procedures

• Establish Quality SOP/WI to support the regulatory and industry (eg. ISO13485) requirements
• Establish and maintain postponement activities such as kitting, labelling, redressing, repackaging etc.
• Support document control activities to ensure that documentation are timely review, revised, and archival of controlled documents in accordance with GDP requirements.
• Oversee qualification of warehouse (IQ,OQ,PQ), including temperature mapping
• Supporting the validation of processes, instruments, and software to ensure they meet quality requirements.
• Managing and reviewing changes to processes and procedures to ensure they do not compromise quality.
• Oversee the proper functioning of temperature and environmental monitoring systems in storage areas.
• Managing deviations from standard procedures, investigating their causes, and implementing effective corrective and preventive actions
• Support risk assessments for storage and distribution processes
• Maintain training matrices and records; monitor compliance with required training.
• Lead and oversee internal and external audit programs to ensure compliance with applicable regulations and standards.
• Track and report on quality related KPI reporting (eg, CAPA closure timeline, etc)
• Provide recommendations for continuous improvement in quality systems, operational procedures, departmental processes, and client work instructions.
• Respond to temperature excursions and environmental deviations, including investigation, documentation, and CAPA implementation.

Qualifications

• Possess a Degree in Science or other relevant fields
• Minimum 5 years of experience managing Quality Management Systems (QMS) and compliance, including in operational Life Sciences and Healthcare environments
• Demonstrable experience managing Quality systems and compliance to Good Manufacturing Practice (GMP), Good Distribution Practices (GDP), and ISO 13485 standards
• Proven ability to collaborate, influence, and work effectively with internal teams, customer stakeholders, and external vendor partners to drive the required business outcomes
• Registered Pharmacist in Singapore and willing to be a license holder for SG Life Science Healthcare facilities will be an added advantage
• Proven leadership, problem-solving, assessing and managing risk, and QA management skills
• Methodical, well organized and process oriented
• Excellent communication and interpersonal skills
• Strategic thinking with attention to details
• Highly motivated, self-starter demonstrating ability to use initiative with respect to scheduled work activities

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