Sr. Executive-QC (Documentation)
3 - 8 Years of ExperienceNot disclosed Full Time
Dasami Lab Pvt Ltd
Hyderabad, Telangana, India
Posted on 18-03-2024
652 Views
1 Vacancy
Description
- Develop, implement, and maintain the documentation system for quality control activities, including document control, change management, and recordkeeping.
- Review and approve quality-related documents, ensuring accuracy, completeness, and compliance with regulatory requirements and company standards.
- Coordinate the creation, revision, and retirement of quality documents, including SOPs, test methods, specifications, protocols, and reports, following established procedures and timelines.
- Provide guidance and support to staff on documentation requirements, procedures, and best practices, ensuring that documentation is clear, concise, and compliant.
- Conduct periodic reviews and audits of documentation systems to ensure integrity, accuracy, and compliance with regulatory requirements and company policies.
- Participate in internal and external audits, including regulatory inspections, by preparing documentation, responding to inquiries, and facilitating audit activities as needed.
- Investigate and resolve documentation-related issues, deviations, and non-conformities, and implement corrective and preventive actions (CAPA) to prevent recurrence.
- Collaborate with cross-functional teams, including Quality Assurance, Manufacturing, Regulatory Affairs, and R&D, to ensure alignment and consistency in documentation practices.
- Stay updated on regulatory requirements, industry best practices, and emerging trends in documentation management and quality control, and recommend process improvements as needed.
Category
Pharmaceuticals
Functional Area
Pharma Quality Control (QC)
Preferred Education
MSc (Master of Science)BSc (Bachelor of Science)
Key Skills
Attention to DetailRegulatory ComplianceDocumentation ManagementQuality Control ProcessesTechnical Writing
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