GMP Specialist - Pharmaceutical Compliance

PT Pharma Excellence Indonesia is seeking a dedicated GMP Specialist to join our team in Bangka Belitung. In this role, you will be at the forefront of ensuring our pharmaceutical facility adheres to the highest standards of Good Manufacturing Practices (GMP). This is an exciting opportunity to drive quality assurance, risk management, and continuous improvement in a dynamic and fast-paced environment.

As a GMP Specialist, you will work closely with cross-functional teams to implement and maintain GMP standards, conduct audits, and ensure compliance with regulatory requirements. You will leverage your expertise in GMP regulations, ISO standards, and pharmaceutical compliance to create a culture of excellence and continuous improvement.

With a salary range of Rp 15,000,000 - Rp 25,000,000 per bulan, this role offers competitive compensation and a comprehensive benefits package. Join us in Bangka Belitung and be part of a team that values innovation, integrity, and excellence.

📋 Tanggung Jawab Pekerjaan

• Develop and implement GMP compliance programs and procedures.
• Conduct internal audits and inspections to ensure adherence to GMP standards.
• Monitor and document compliance with regulatory requirements.
• Provide training and guidance to staff on GMP regulations and best practices.
• Collaborate with cross-functional teams to identify and mitigate risks.
• Ensure continuous improvement of processes and procedures.
• Maintain accurate and up-to-date records of compliance activities.
• Participate in regulatory inspections and audits.

🎓 Kualifikasi & Syarat

• Bachelor's degree in Pharmacy, Chemistry, or related field.
• Minimum 5 years of experience in GMP compliance and pharmaceutical manufacturing.
• Certification in GMP (e.g., GMP, ISO 13485, or equivalent).
• Familiarity with pharmaceutical regulations and standards.
• Strong knowledge of GxP regulations (GMP, GLP, GCP).
• Excellent communication and interpersonal skills.
• Ability to work independently and as part of a team.
• Proficient in using Microsoft Office Suite and GMP-specific software.

🛠️ Keahlian

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