Product Quality Executive

PRESTIGE BIOPHARMA LIMITED; Singapore; On-site; SGD 120,000 - 180,000; Full time

Job summary

PRESTIGE BIOPHARMA LIMITED is seeking a QA professional to lead the implementation of the Quality Management System in accordance with cGMP and international regulations. You will update complaints, escalate into CAPA, and review test protocols, batch records and analytical data to ensure product quality meets requirements.

You will lead internal audits and audits of CMOs, provide training on QA procedures, mentor junior staff, and collaborate with cross-functional teams to ensure regulatory

Qualifications

• Degree in Engineering (Biomedical) or Degree in Science (Biology, Chemistry, Bio-engineering)
• 3–5 years' experience in biopharmaceutical quality assurance.
• Experience in bioprocessing technology (upstream and downstream).
• 3–5 years' experience in pharmaceutical quality assurance, focusing on product quality management and compliance.

Responsibilities

• Lead in the implementation of Quality Management System in accordance with internal company policies and procedures, cGMP and other international regulations.
• Update complaints retrieved from various sources to complaint log in a timely manner and escalates complaints into the CAPA system following review.
• Participate in Product Quality activities by reviewing test protocols, reports, batch records and analytical data to ensure product quality meet the specified requirements.
• Review OOS investigation, deviation, CAPA and risk management for products as required.
• Review product quality documents and provide documents related to product quality upon request.
• Draft and review Quality Technical Agreements
• Provide management with quality data and trends as required.
• Lead internal audits to ensure the effective implementation of Quality Management System as required.
• Lead audits in DS and DP CMOs to ensure compliance to all relevant guidelines, regulations and agreements.
• Provide training and guidance to personnel on quality assurance procedures, regulations, and best practices.
• Mentor junior QA staff and contribute to their professional development.
• Any other duties as assigned by supervisor.

Skills

Analytical skills

Problem solving

Computer skills

Attention to detail

Collaboration

Communication skills

Audits

Team player

Independent worker

Deadline oriented

Education

Degree in Engineering (Biomedical) or Degree in Science (Biology, Chemistry, Bio-engineering)

Job description

Job Responsibilities

• Lead in the implementation of Quality Management System in accordance with internal company policies and procedures, cGMP and other international regulations.
• Update complaints retrieved from various sources to complaint log in a timely manner and escalates complaints into the CAPA system following review.
• Participate in Product Quality activities by reviewing test protocols, reports, batch records and analytical data to ensure product quality meet the specified requirements.
• Review OOS investigation, deviation, CAPA and risk management for products as required.
• Review product quality documents and provide documents related to product quality upon request.
• Draft and review Quality Technical Agreements
• Provide management with quality data and trends as required.
• Lead internal audits to ensure the effective implementation of Quality Management System as required.
• Lead audits in DS and DP CMOs to ensure compliance to all relevant guidelines, regulations and agreements.
• Provide training and guidance to personnel on quality assurance procedures, regulations, and best practices.
• Mentor junior QA staff and contribute to their professional development.
• Any other duties as assigned by supervisor.

Education/Qualification

• Degree in Engineering (Biomedical) or Degree in Science (Biology, Chemistry,
• Bio-engineering)
• Experience in quality function dealing with Biopharmaceuticals with 3 to 5 years experience.
• Experience in Bioprocessing Technology (Upstream and Downstream operations).
• Minimum of 3-5 years of experience in pharmaceutical quality assurance, with a focus on product quality management and compliance.

Skills preferred

• Strong analytical and problem-solving skill
• Good computer skills, inclined to adapt to technology efficiently.
• Results-oriented, multi-tasking, quick learner
• Works independently and well under tight deadlines
• Good knowledge and thorough understanding of cGMP, FDA regulations, ICH guidelines, and other relevant regulatory guidelines and quality standards.
• Strong analytical skills and attention to detail, with the ability to critically evaluate data and identify trends.
• Excellent oral and written communication skills, with the ability to effectively collaborate with cross-functional teams and communicate complex issues to diverse audiences.
• Proven track record of conducting audits, investigations, and implementing corrective actions.
• Team-player