Summary
Date Posted: Friday, October 27 2023, Base Salary: Not Disclosed

JOB DETAILS:
Job Summary:
The In-process Quality Controller will be responsible for ensuring that all manufactured products meet the quality standards for both the company and the regulatory bodies. This role involves implementing quality control procedures, conducting rigorous inspections, performing analytical testing, and collaborating with cross-functional teams to maintain product specifications, integrity and compliance to regulatory and statutory requirements.

Responsibilities:
1. Analytical Testing:
• Perform analytical tests on raw materials, in-process samples, and final products using sophisticated equipment, and techniques in line with MHS’s standard procedures.
• Evaluate test results for accuracy, precision, and correctness.
• To be responsible for the statistical analysis of product quality information and measurement data, determine improvement measures, and evaluate the quality stability of materials, intermediate products and finished products
• To be responsible for the daily management of testing tools and instruments; organize verification and calibration-related facilities and equipment
• To be responsible for environmental monitoring of clean plant and quality monitoring of purified water
2. Inspections and Audits:
• Responsible for coordinating inspection-related matters with the business departments, such as order processing, publishing inspection results, and other related tasks
• Responsible for analyzing inspection anomalies
• Participate in internal and external audits, responding to audit findings and implementing corrective actions especially related to quality control tests, procedures and laboratory equipment
• Inspection of semi-finished and finished products, and retention of finished products samples
• Responsible for completing inspection tasks in a timely manner
• Responsible for maintaining proper inspection records and issuing inspection reports
• Responsible for retaining samples of finished products
3. Documentation and Record Keeping:
• Maintain and retain accurate and detailed records of all quality control activities, including test results, inspection reports, and corrective actions taken.
• Ensure proper documentation practices for compliance with statutory and regulatory requirements.
4. Data Analysis and Reporting:
• Analyse quality data to identify trends, potential risks, and areas for improvement.
• Prepare comprehensive reports on quality control findings and communicate them to relevant stakeholders.
5. Training and Compliance:
• Provide regular trainings to new employees on quality control test procedures
• Responsible for maintaining the 6S (Sort, set in order, Shine, Standardize, Sustain, Safety) in the laboratory
• Adhere to good laboratory practices
• Ensure that all quality control practices are aligned with regulatory and statutory requirements.

Qualifications:
• Bachelor’s or Master’s degree in Pharmacy, Chemistry, Pharmaceutical Sciences, Bio-medical engineering, Laboratory technology, or a related field.
• A minimum of 4 years’ experience in a quality control position in a pharmaceutical industry
• Must be familiar with ISO 9001, ISO 13485
• Familiar with the following tests: Package tension test, Package sealability test, molecular PCR test, Antigen Immunochromatography test, RDT
• Extensive knowledge of medical devices regulations, including Good Manufacturing Practices (GMP, GLP).
• Good experience in quality control procedures in medical devices including RDT and molecular based diagnostics testing kits.
• Relevant certifications (e.g., ASQ Certified Quality Auditor, Certified Quality Control Analyst) are a plus. Experience with quality management systems (QMS) and electronic documentation systems.
• Strong analytical and problem-solving skills.
• Excellent communication skills both oral and written for effective collaboration with cross-functional teams and regulatory authorities.
• Attention to detail and a strong commitment to maintaining the highest quality standards.



Work Hours: 8

Experience in Months: 48

Level of Education: Bachelor Degree

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