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

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

Quality Assurance - Pharmaceutical & LifeSciences