Job Title: Pharmaceutical Batch Document Specialist
We are seeking a detail-oriented and organized professional to join our team as a Pharmaceutical Batch Document Specialist. In this role, you will be responsible for reviewing and assessing manufacturing and packaging batch records for accuracy, completeness, and compliance with GMP and company standards. Your attention to detail and strong organizational skills will ensure timely resolution and escalation of discrepancies, deviations, or non-conformities.
This position requires a solid understanding of GMP guidelines and pharmaceutical manufacturing processes. You will work closely with production, quality assurance, and regulatory teams to ensure proper documentation practices. Additionally, you will maintain up-to-date knowledge of regulatory requirements and company SOPs.
The ideal candidate will have previous experience (minimum 1 year) in batch record review within the pharmaceutical industry. Proficiency in English (written and spoken) is also essential.
Key Responsibilities:
- Review and assess manufacturing and packaging batch records for accuracy, completeness, and compliance with GMP and company standards.
- Identify and document discrepancies, deviations, or non-conformities, ensuring timely resolution and escalation as needed.
- Collaborate with production, quality assurance, and regulatory teams to ensure proper documentation practices.
- Maintain up-to-date knowledge of regulatory requirements and company SOPs.
- Assist in audits and inspections by providing relevant documentation and explanations.
Requirements:
- Previous experience (minimum 1 year) in batch record review within the pharmaceutical industry.
- Solid understanding of GMP guidelines and pharmaceutical manufacturing processes.
- Attention to detail and strong organizational skills.
- Proficiency in English (written and spoken).