Sr. Executive-Production (Documentation)

3 - 12 Years of Experience rupess outline icon

Not disclosed time outline icon

Full Time

Dasami Lab Pvt Ltd

time outline icon Hyderabad, Telangana, India

Posted on 18-03-2024

827 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.