Global Quality System Principal Specialist | Pharmaceutical | JIAW (ID:672409)

PERSOLKELLY Singapore Pte Ltd (Formerly Kelly Services Singapore Pte Ltd); Singapore; On-site; USD 60,000 - 100,000; Full time

Job summary

An established industry player is seeking a Quality Management Specialist to lead the development and maintenance of global quality standards. This role is pivotal in ensuring compliance with international regulations and enhancing the quality management system across multiple sites. The ideal candidate will have extensive experience in the pharmaceutical sector, with a strong grasp of Good Clinical Practices and regulatory requirements. Join a dynamic team where your expertise will drive continuous improvement and sustainability in quality functions, making a significant impact on product lifecycle management.

Qualifications

• 7+ years of experience in quality management in the pharmaceutical industry.
• Strong understanding of global regulatory laws and guidelines.

Responsibilities

• Develop and maintain global quality standards and documentation.
• Oversee quality management system compliance and effectiveness.

Skills

Quality Management Systems

Pharmaceutical Regulations

Good Clinical Practices (GCP)

Good Manufacturing Practices (GMP)

Risk Management

Document Control

Cross-Functional Communication

Education

Bachelor's Degree in Pharmaceutical Engineering

Master's Degree in Biotechnology

Job description

Job Summary:

Responsible for the establishment and maintenance of the global quality management system, and for advancing the implementation of quality system requirements across global sites.

Job Responsibilities:

1. Assists in developing, implementing, and maintaining global quality standards that comply with international regulations and guidelines. This could involve creating standard operating procedures (SOPs), quality manuals, and other documentation.

2. Participates in overseeing the quality management system (QMS) to ensure its effectiveness and compliance with global regulatory requirements. This includes managing document control, audits, corrective and preventive actions (CAPA), and continuous improvement processes.

3. Working closely with other departments, such as R&D, manufacturing, and supply chain, to ensure quality considerations are integrated throughout the product lifecycle.

4. Provide cross-functional support to internal Global Quality Standard & Operation departments to ensure sustainability and continuous improvement in all compliance and quality functions.

5. Participates in identifying and assessing quality-related risks and implementing risk management strategies to mitigate these risks. Provide Global Learning and quality Metrics while reporting Quality Risk to Quality Leadership Team, handling global and multi-site change control as well as multi-site CAPAs for the Networks.

Requirements:

1. Pharmaceutical engineering, biotechnology, or related majors, with a bachelor's degree or higher.

2. Minimum seven years of relevant experience in quality management within the pharmaceutical industry, especially in designing, implementing, and maintaining global quality management systems. Relevant experience will be given priority consideration.

3. Familiarity with global pharmaceutical regulatory laws and guidelines, including but not limited to regulations from agencies such as the FDA, EMA and NMPA.

4. Have good communication skills and be capable of effective communication in a cross-regional and cross-cultural environment.

5. Thorough knowledge of Good Clinical Practices (GCP) and Good Manufacturing Practices (GMP)of on biological API.

6. Detailed knowledge in the design, implementation, and maintenance of Quality Management Systems.

7. Well understood the drug substance manufacturing process.

Interested candidates who wish to apply for the advertised position, please click on “Apply”. We regret that only shortlisted candidates will be notified.

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