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A Team Member/Subject Matter Expert (SME) is a role in which an individual is responsible for providing expertise and knowledge in a specific area or subject. This can include technical skills, industry knowledge, or specialized experience. The role typically involves working with a team to complete projects and tasks, and may include responsibilities such as problem-solving, training others, and providing guidance and support.
Biologics
1
Skills required: The skills required for this role would likely include strong communication skills to effectively work with team members and convey technical information, as well as an ability to identify patterns and attention to detail in order to ensure product quality. Team playing is also essential, as the role involves working closely with others to achieve common goals. Strong driving skills, may be required for the individual to lead or manage the team or projects.
Hyderabad, Telangana, India
M Sc
8 to 11 Years
Job Description :
Quality Management Systems & Governance To respond to the customer queries timely.
To review the quality agreements received from the customers.
To fill the customer questionnaires timely and to prepare the product related declarations.
To share the documents to RA for submission of product dossier to regulatory agencies in various geographies.
Document collection, Review and sharing to Regulatory team for filings (New and Amendments), deficiency or queries.
Review and approving of Process Descriptions, Quality Equivalences, Equipment lists etc.
Preparation and review of category Incidents trends as per defined procedures.
Preparation and review of OOS, OOT, Complaints investigation reports.
Handling of Return goods and CAPA related to incidents, OOS, OOT and Complaints.
Preparation, Review & Approval of all master documents.
Prepare, review and approvals of different study protocols and reports as per requirement of defined procedures.
Preparation and review of Annual Review Reports as per the time lines.
Review of Risk Assessment reports and approval.
Quality Assurance Associate (QMS)
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To apply for this job email your details to grandirpharma@gmail.com