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A leading manufacturing company seeks a quality assurance specialist to oversee lab operations and ensure compliance with environmental policies. The candidate will lead projects requiring microbiological and chemical evaluations while managing lab analysts' performance. Ideal for individuals with a Bachelor's in Science and relevant experience in laboratory environments.
Essential Duties and Responsibilities:
1. Product/ Systems are released in a timely manner:
a) Monitor and ensure that periodic tests are carried out.
b) Review and ensure equipment and material availability.
c) Review Extra Ordinary Maintenance (EOM) and recommends required monitoring/ evaluation requirements.
d) Ensure proper scheduling and staffing of processes to complete the test and products are tested per requirements.
2. Results of analysis are accurate and reliable:
a) Ensure equipment/ rooms are calibrated and/ or validated and procedures are documented and, if necessary, validated.
b) Review training/ coaching requirements for Lab Analysts and evaluation of Lab Analysts’ performance.
c) Ensure proper documentation requirements for various activities are met.
3. Exceptions are resolved in a timely manner:
a) Perform Lab OOL investigation and ensure appropriate documentations are completed on time.
b) Analyze test OOLs and provide disposition accordingly and review OOL results with process owner and Engineer.
c) Assist/ Recommend Corrective Action/ Preventive Actions (CAPA) and continuous improvement ideas.
d) Follow-up to ensure committed actions are implemented and effective.
e) Prepare Non Conformance Report (NCR) and investigate Out of Tolerance (OOT) for Calibration issues.
4. Support Projects requiring Microbiological/ Chemical evaluation are supported:
a) Participate in Project Groups in assigned area of responsibility.
b) Consult Corporate/ provide recommendation on how to meet project’s microbiological evaluation requirements.
c) Schedule to perform the required microbiological/ chemical tests/ internal review and schedule with Corporate to perform the required microbiological tests/ review.
5. Lead assigned projects:
a) Determine project requirements and assign responsibilities to team members and assign tasks and timeline to members.
b) Solicit and review recommendations/ feedback from team members and follow up to ensure project conclusion.
6. Safe and Healthy work environment are maintained:
a) Review housekeeping audit schedule and audit housekeeping and work practices.
b) Communicate safe practices and housekeeping requirements and recommend and/ or implement necessary improvement actions.
7. Responsible for compliance to EHS procedure and requirement.
Qualifications/ Education:
· Diploma /Bachelor of Science (Microbiology /Chemistry) or related field or equivalent
Skill Set and/or Experience:
· Fresh Degree /Diploma with Min 3 years or
· Degree with Min 3 years /Diploma with Min 6 years
· Some relevant working Experience
· Technical knowledge on lab equipment/ system/ software/ validations