Quality Assurance Professional
1 day ago
We are seeking a highly skilled Quality Assurance Professional to join our team at RECRUIT EXPRESS PTE LTD.
About the JobThis is a fantastic opportunity for someone with a passion for ensuring quality and compliance in the pharmaceutical industry.
The successful candidate will have a minimum of 2-3 years of experience in quality assurance, manufacturing operations, or validation, ideally in a multinational company.
They will be responsible for supporting site projects on qualification/validation, reviewing and approving quality control related protocols, reports, procedures, and other documents.
The ideal candidate will have hands-on experience in performing equipment, process, cleaning, computer systems, and shipping validation, as well as knowledge of FDA/EU cGMP validation requirements/expectations and ICH guidelines.
Key Responsibilities- Support site projects on qualification/validation.
- Review and approve quality control related protocols, reports, procedures, and other documents.
- Evaluate and approve discrepancies related to qualification/validation protocols.
- Collaborate and participate in projects as a quality representative for quality systems and validation.
- Provide validation expertise and support for analytical instrument qualification, analytical and microbiology method validation, and critical reagent qualification.
- Ensure information in approved qualification/validation documents is understandable and defendable during inspections.
- Provide quality oversight on quality control validation maintenance activities and the master validation plan.
- Support multisite initiatives to harmonize quality systems and qualification/validation activities between plants.
- Build strong partnerships with other departments to ensure open communication and acceptance.
- Adhere to applicable EHS requirements.
- Min. degree in pharmaceutical sciences, life sciences, biology, biotechnology, chemistry, chemical engineering, engineering, or a related discipline.
- Additional certifications and training such as certified quality engineer or specific validation topics are advantageous.
- Minimum of 2-3 years of experience in the pharmaceutical or biotechnology industry in quality assurance, manufacturing operations, or validation, ideally in a multinational company.
- Hands-on experience in performing equipment, process, cleaning, computer systems, and shipping validation is advantageous.
- Knowledge of FDA/EU cGMP validation requirements/expectations (e.g., CFR 21 part 11, PAT) and ICH guidelines.
We offer a competitive salary range of $6000-8000 per month, depending on experience.
This is a full-time position based in Kranji, Singapore, working from Monday to Friday, office hours.
We believe in providing a supportive and collaborative work environment that allows our employees to grow and develop their careers.
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