Assistant Manager – DQA (Formulation R&D)
Location: Jeedimetla, Hyderabad, Telangana, India
Employment Type: Permanent
Department: Formulation Research & Development – DQA
Experience Required: 5–8 Years
Education: M.Pharmacy
Job Overview
We are seeking an experienced Assistant Manager – DQA (Formulation R&D) to ensure quality compliance, documentation accuracy, and regulatory readiness for formulation research and development activities. This role focuses on implementing robust DQA systems, reviewing technical documents, supporting audits, managing deviations, and facilitating smooth technology transfers. The position requires expertise in cGMP, GLP, ICH guidelines, and regulated market compliance.
The ideal candidate will have hands-on experience in DQA for formulation R&D, strong analytical skills, and the ability to collaborate with cross-functional teams in a fast-paced pharmaceutical environment.
Key Responsibilities
1. DQA Oversight for Formulation R&D
Ensure compliance of formulation R&D activities with cGMP, GLP, and internal quality systems.
Monitor adherence to SOPs, protocols, and regulatory guidelines during all development activities.
2. Documentation Review & Control
Review and approve R&D documents including:
Development reports
Stability protocols and reports
Technology transfer documents
Lab notebooks (LNB/e-LNB)
Specifications, IOCS, and change controls
Ensure all documentation is accurate, traceable, and audit-ready.
3. Deviation, OOS & CAPA Management
Review and assess deviations, OOS/OOT, incidents, and investigations related to formulation R&D.
Ensure timely root cause analysis, CAPA implementation, and effectiveness checks.
4. Regulatory & Audit Support
Support internal, external, and regulatory audits (USFDA, EU, WHO).
Coordinate audit responses, documentation readiness, and follow-up actions.
Ensure R&D data compliance for regulatory submissions.
5. Change Management & Risk Assessment
Review and manage change controls related to formulations, processes, and analytical methods.
Participate in risk assessments (FMEA) and provide quality input during development and scale-up.
6. Technology Transfer & Scale-Up Support
Provide DQA support during product transfer from R&D to pilot or commercial manufacturing.
Ensure quality considerations are addressed during scale-up and validation activities.
7. SOPs & Training
Review, update, and implement SOPs related to R&D quality systems.
Conduct training for R&D teams on quality practices, documentation standards, and compliance expectations.
8. Cross-Functional Coordination
Collaborate closely with FRD, AR&D, CQA, Regulatory Affairs, and Manufacturing teams to integrate quality into all stages of R&D.
Required Skills & Competencies
Strong understanding of cGMP, GLP, ICH guidelines, and global regulatory expectations.
Hands-on experience in DQA for formulation R&D.
Expertise in documentation review, compliance, and audit handling.
Exposure to regulated markets (US/EU) preferred.
Strong analytical, communication, and coordination skills.
Ability to mentor junior team members and drive quality culture.
Preferred Experience
Experience with oral solids, injectables, or complex formulations.
Exposure to electronic documentation systems (e-LNB, EDMS).
Familiarity with technology transfer and scale-up activities.
Why Join
Work in a regulated, GMP-compliant formulation R&D environment.
Contribute to quality systems, regulatory readiness, and scientific documentation excellence.
Collaborate with cross-functional teams and participate in global audits and regulatory submissions.
Opportunity to grow as a quality and compliance leader in pharmaceutical R&D.
Explore more global pharmaceutical, formulation, and quality assurance roles at
thepharmadaily.com
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