Senior Quality Assurance Specialist for Pharmaceutical Projects

6 days ago


Singapore Antaes Consulting SA Full time
Job Description:

We are seeking a highly skilled Senior Quality Assurance Specialist to join our team at Antaes Consulting SA. As a key member of our quality assurance department, you will play a vital role in ensuring the highest standards of quality and compliance in our pharmaceutical projects.

About the Role:
As a Senior Quality Assurance Specialist, your primary responsibility will be to contribute to Life Science projects for our clients. You will perform detailed reviews of raw materials, intermediate products, and finished products to ensure compliance with quality specifications. Your expertise will also be utilized to manage the release process by ensuring all quality checks are completed before approving materials and products for use or distribution.

Your Key Responsibilities will include:
1. Conducting regular GEMBA (on-site workplace observation) and GMP (Good Manufacturing Practice) walk-throughs of the manufacturing floor to identify potential quality risks, ensure compliance, and promote a culture of continuous improvement;
2. Reviewing, revising, and approving Standard Operating Procedures (SOPs), forms, and Manufacturing Batch Records to ensure they are up-to-date and compliant with current regulations and company policies;
3. Collaborating with manufacturing teams to address any quality-related issues that arise during production and ensuring prompt resolution;
4. Providing on-site quality oversight during the manufacturing process to ensure that all operations comply with Good Manufacturing Practices (GMP) and company quality standards;
5. Ensuring that all documentation aligns with current industry standards and best practices in pharmaceutical manufacturing;

Requirements:
To succeed in this role, you will need:
1. A Bachelor's degree in Biotechnology, Pharmaceutical or related field;
2. 3-5 years of experience in quality assurance within the pharmaceutical or biotechnology industry;
3. Strong knowledge of GMP (Good Manufacturing Practices) and regulatory compliance;
4. Hands-on experience in conducting GEMBA or GMP walk-throughs and identifying quality risks;
5. Proficient in reviewing and approving procedures such as SOPs, forms, and batch records;
6. Excellent communication and collaboration skills to work with cross-functional teams;
7. Good communication and problem-solving skills;

What We Offer:
We value diversity and equality in the workplace and welcome applications from all qualified candidates. Our positions are open to people who have been recognized as disabled workers.

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