Company Name: PT Amarox Pharma Global
Location: Cikarang Pusat
Posted Date: 25/09/2024 23:28
Salary:
Job Description
Job Purpose:
- Ensure discrepancies, deviations, and change controls are followed up and align with Good Manufacturing Practice (GMP), Good Laboratory Practice (GLP), and company procedures to prevent reoccurrences.
Job Role:
Quality Systems Management:
Oversee and improve quality assurance systems to ensure compliance with GMP, GLP, and regulatory standards.
Regulatory Compliance:
Ensure all products and processes comply with relevant regulatory requirements and industry standards.
Audits and Inspections:
Conduct internal audits and prepare for external inspections by regulatory authorities.
Documentation:
Maintain accurate and thorough documentation of quality processes, deviations, and corrective actions.
Training:
Provide training to staff on quality assurance procedures and regulatory requirements.
Issue Resolution:
Identify and resolve quality issues, implementing corrective and preventive actions.
Continuous Improvement:
Drive continuous improvement initiatives to enhance product quality and compliance.
Reporting:
Generate reports on quality performance and compliance status for management review.
Investigation and Reporting:
Investigate discrepancies, deviations, and change controls on procedures and create comprehensive reports.
CAPA Follow-Up:
Follow up on corrective and preventive actions (CAPA) to avoid reoccurrences.
GMP Training:
Prepare and conduct GMP training refreshers for all departments and update training modules.
Quality Reports:
Create monthly quality progress reports on discrepancies, deviations, change controls, CAPA, and training.
Implementation Assurance:
Ensure the effective implementation of GMP/GLP practices within the plant.
Requirements:
- Bachelor’s degree in Pharmacy is a must
- Proven experience as a supervisor in the Quality Assurance department within the pharmaceutical industry.
- In-depth knowledge of GMP, GLP, and regulatory requirements.
- Strong analytical and problem-solving skills.
- Excellent communication and interpersonal skills.
- Attention to detail and strong organizational abilities.
- Experience with internal and external audits.
- Ability to work in a fast-paced and dynamic environment.
Why Join Us:
Mission-Driven Culture:
At PT Amarox Pharma Global, we are driven by a shared mission to provide high-quality pharmaceutical products and make a positive impact on global healthcare. Every member of our team plays a crucial role in fulfilling this mission, creating a sense of purpose and fulfillment in our work.
Opportunities for Growth:
We believe in investing in our employees’ growth and development. As a member of our team, you’ll have an opportunity for career advancement paths that will help you reach your full potential.
Collaborative Environment:
We foster a collaborative and inclusive work environment where everyone’s ideas are valued and respected. You’ll have the opportunity to work closely with cross-functional teams and contribute to innovative solutions that drive our success.
Commitment to Excellence:
Quality is at the heart of everything we do. We are committed to upholding the highest standards of quality and compliance in all aspects of our work, ensuring that our products meet the highest regulatory standards and exceed customer expectations.