Sr. Executive-Production (Documentation)
3 - 12 Years of ExperienceNot disclosed Full Time
Dasami Lab Pvt Ltd
Hyderabad, Telangana, India
Posted on 18-03-2024
823 Views
1 Vacancy
Description
- Develop and implement documentation procedures and protocols to ensure accurate recording of production processes, including batch records, standard operating procedures (SOPs), and work instructions.
- Review and update production documentation to ensure compliance with regulatory standards, quality standards, and company policies, including Good Manufacturing Practices (GMP) and ISO requirements.
- Collaborate with production staff, quality control personnel, and regulatory affairs team to gather information, verify data accuracy, and resolve discrepancies in production documentation.
- Maintain and manage documentation databases, electronic document management systems (EDMS), and file repositories to ensure accessibility, organization, and version control of production documents.
- Provide training and support to production staff on documentation procedures, record-keeping requirements, and use of documentation systems to ensure adherence to established protocols.
- Conduct internal audits and inspections of production documentation to identify gaps, non-conformities, and opportunities for improvement, and implement corrective actions as needed.
- Coordinate with external auditors and regulatory agencies during inspections and audits, providing documentation and supporting evidence as required to demonstrate compliance with regulatory requirements.
- Participate in cross-functional teams and projects related to documentation management, quality assurance, and continuous improvement initiatives within the production department.
- Stay updated on regulatory changes, industry best practices, and emerging trends in documentation management, quality assurance, and regulatory compliance, and recommend process improvements accordingly.
Category
Pharmaceuticals
Functional Area
Production / Manufacturing
Preferred Education
MSc (Master of Science)BSc (Bachelor of Science)
Key Skills
Attention to DetailQuality AssuranceRegulatory ComplianceTechnical WritingDocumentation Management
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