Qualification:

• Master’s in Pharmaceuticals/PhD with relevant post-qualification experience in the formulation and quality documentation

Experience: 2-8 years of experience in handling formulation documents

Min. Qualification required to man the position: B pharma OR Postgraduate degree (preferably Pharma, Life sciences) with a deep understanding of formulation and quality documentation

ROLE DESCRIPTION

1. ROLE OBJECTIVE/PURPOSE

• Strong understanding of formulation and quality documents (e.g. Master Formula Card, Specifications etc) and hands-on experience in data verification
• Validate the data extracted from various documents using a tool and transfer of information into the required format in accordance with GxP standards

1. DETAILED DUTIES AND RESPONSIBILITIES, wherever applicable

Key Responsibility Indicators

• Assist in establishing GxP compliant documentation for the entire process including data extraction from unstructured data sources followed by verification of the extracted data
• Lead the team of associates engaged in data verification
• Provide timely feedback to the AI product team for data deficiencies in data extraction
• Thorough review of formulation documents including MFC, product specification and raw material specification
• Understand the content highlight variations within a set of given documents
• Word-to-Word verification of AI generated output in tabular format against the data available in source documents
• Ensure GxP compliance of the review process

People Related:

• Team work - Collaborate with the team, good interpersonal communication, professional conduct, actively participate in team related activities

Process Related:

• Domain Expertise - Demonstrating expertise or quickly gaining knowledge and building expertise in an area of interest
• Efficiency –Critically evaluate information and organize data for analysis and maintain data records
• Accuracy - Ability to assess accuracy of information gathered, data gaps if any and steps to plug in the data gaps
• Presentation of reports – Good documentation knowledge with well- structured and formatted content, correct usage of English language, usage of right templates and audience-appropriate representations.

Must have:

• Postgraduate degree with a specialization in formulation and quality documentation or a related field
• Strong understanding of formulation and quality documents along with the databases where these documents are managed
• Hands on experience in validating the data available in the documents such as Master Formula Card, Specifications etc and databases where these are documents are managed
• Ability to verify AI generated outputs with the information available in source documents.
• Solid foundation in raw material, finished product, and project management, with the ability to apply these skills across data verification process
• Knowledge on MS Office (esp. Word and basic Excel)
• Knowledge of Databases containing formulation and quality documentation
• Must exhibit following core behaviors:
• Taking ownership / accountability of the projects assigned
• Flexibility to work on cross-team projects across all domains
• Attention to details
• Clear/concise and effective communication
• Critical thinking
• Self-motivated, able to work autonomously and self-disciplined