Sr. Executive-Production (Documentation)

Sr. Executive-Production (Documentation)

work outline icon3 - 12 Years of Experiencerupess outline iconNot disclosed time outline iconFull Time

Dasami Lab Pvt Ltd

time outline iconHyderabad, 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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