DQA - Development Quality Assurance (Formulation)

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About Graviti Pharmaceuticals

Graviti Pharmaceuticals is a research-driven formulation company based in Hyderabad, specializing in complex generics, modified-release technologies, stability-sensitive molecules, and novel drug delivery systems. We maintain high-quality standards and strong scientific capabilities to support global regulatory expectations.

sister concern of the prestigious Yashoda Group of Hospitals

About the Role

Development Quality Assurance (DQA) Manager / Senior Manager

Key Responsibilities

1. Development Quality Assurance

• Oversee all DQA activities for new product development, including pilot, exhibit, process validation, and qualification batches.
• Review and approve:
• Product Development Reports (PDR)
• Master Formula Records (MFR/MFC)
• Master Packing Records (MPR/MPC)
• Specifications, STPs, and analytical reports
• Compatibility and stability study protocols
• Ensure compliance for FRD, FARD, ARD, and PKD labs.
• Oversee DOE reviews, residual solvent assessments, elemental impurity evaluations, and stability plans.

2. Regulatory & Audit Preparedness

• Coordinate with Regulatory Affairs for ANDA, EU DCP, and global submissions.
• Support regulatory audits including USFDA, EMA, and other international inspections.
• Review CMC sections, analytical validations, and development data required for dossier filing.
• Lead internal audits, CAPA implementation, and continuous improvement initiatives.

3. Vendor & External Site Quality

• Evaluate and qualify vendors including CROs, API suppliers, excipient suppliers, and service providers.
• Lead and support vendor audits; ensure timely closure of audit observations.
• Oversee external manufacturing quality including batch reviews, packaging approvals, deviations, OOS/OOT, market complaints, and recall readiness.

4. Quality Management Systems

• Manage change controls, deviations, investigations, and CAPA.
• Maintain and support DMS and e-systems such as:
• SAP QM
• iLearn Training Module
• DOC-Hub
• KAROMI Artwork system
• Ensure strong QMS compliance across all development laboratories.

Key Skills & Competencies

• Strong understanding of cGMP, GLP, ICH, USFDA, and EU guidelines
• Expertise in formulations including Tablets, Capsules, Injectables, Liquids, Ointments, Topicals, Pellets
• Strong skills in analytical method development, validation, and interpretation
• Excellent documentation, audit handling, and regulatory compliance skills
• Effective cross-functional coordination with R&D, RA, QC, QA, and Production teams

Educational Qualification

• M.Sc (Chemistry) / B.Pharm / M.Pharm or equivalent

Preferred Background

• Experience in Development QA within major pharmaceutical organizations
• Exposure to USFDA audit readiness and CMC documentation
• Experience in regulated market submissions (US/EU)

Who Should Apply

• Professionals with 12–18 years of experience in DQA / QA / CQA / RA-CMC
• Candidates with strong documentation and formulation development QA experience
• Experience in both API and formulation QA is an added advantage