- Provides strong, independent technical leadership to technical personnel.
- Lead, design and performs method development and validation of new test procedures for incoming projects.
- Functions as Technical Reviewer for A2LA accredited tests and non-accredited tests.
- Evaluates analytical results to form interpretations of data and renders scientific opinions for client-driven projects.
- Serves as subject matter expert in area of specialization, established standards for regulatory compliance.
- Serves as technical liaison with Customers with regards to technical services and performs Customer Site Visits where required.
- Prepares documents including methods, procedures, standard operating procedures, study protocols, summary reports.
- Assures that SOPs are in accordance to ISO 17025, cGMP and other regulatory requirements.
- Provides problem-solving skills for test procedures and investigations within laboratory unit.
- Responsible for notifying Quality Assurance and Senior Management of any compliance deficiencies or concerns in timely manner.
- Monitor all proficiency-based testing and ensure compliance.
- Participates in Internal Quality Audits, System Audits, Audits conducted by external agencies and Regulatory Authorities.
- Participate in quarterly management review.
- Drive process, quality and safety improvement initiatives within the department.
- Provide coaching and mentoring to Technical personnel.
- Supports the Laboratory Manager in all relevant functions
JOB REQUIREMENTS
- Bachelor of Science or related degree, MSc. preferred but not essential.
- Minimum 6 years relevant QC microbiological experience in regulated laboratory, minimum 2 of which should be in a supervisory role.
- Experience in method validation, method transfer, qualifications activities in regulated laboratory.
- Good knowledge of ISO17025, cGMP and other regulatory guidelines.
Office hours, Mon to Fri
Lab Testing MNC
Interested candidates, do submit your resume to : jocelynchan@recruitexpress.com.sg OR telegram @jocelynchan
Jocelyn Chan| Consultant | Recruit Express Pte Ltd (Healthcare & Lifescience)
Company EA Licence number : 99C4599
Personnel EA License: R1331820
