● Draft quality assurance policies and procedures.
● Interpret and implement quality assurance standards.
● Evaluate adequacy of quality assurance standards.
● Devise sampling procedures and directions for recording and reporting quality data.
● Review the implementation and efficiency of quality and inspection systems.
● Plan and monitor testing and inspection of materials and products to ensure finished product quality.
● Document internal audits and other quality assurance activities.
● Investigate customer complaints and non-conformance issues.
● Collect and compile statistical quality data.
● Analyze data to identify areas for improvement in the quality system.
● Develop, recommend and monitor corrective and preventive actions.
● Prepare reports to communicate outcomes of quality activities.
● Identify training needs and organize training interventions to meet quality standards.
● Coordinate and support on-site audits conducted by external providers.
● Evaluate audit findings (internal or external audits) and implement appropriate corrective actions.
● Monitor risk management activities.
● Assure ongoing compliance with quality and industry regulatory requirements.
● Ensuring that manufacturing processes comply with GMP standards at both national and international level.
● Analyze the data and recommend changes to production processes or quality controls according to change control system to eliminate the problem.
● Analyze records of product returns to identify specific problems or trends over time.
● To prepare documentation and reports by collecting, analyzing and summarizing information and trends including failed processes, stability studies, recalls, corrective actions.
● Validate quality processes by establishing product specifications and quality attributes and re-validations.
● Develop & implement quality assurance training programs.
● Preparing all quality department SOPs.
Requirements
● Education: Doctor of Pharmacy or PhD.
● Work experience: Minimum 4 years’ experience as a quality assurance manager in pharmaceutical manufacturing company.
Competencies:
● Leadership Skill.
● Problem solving skill.
● Communications & interpersonal skills.
● Attention to detail.
● Analytical thinking.
● Maturity.
● Result Oriented.
● Excellent documentation skills.
Others:
● Fluent in English.
● Excellent MS Office knowledge (Excel, Word, PowerPoint).
● Good numerical skill and an understanding of statistic.
● Must be familiar with Local regulatory affairs and EU GMP standards.
● Frequent traveling availability.