Website:
morepenpdr.com
Job details:
💊 Job Title: Assistant Manager / Deputy Manager – Development Quality Assurance (API R&D)
📍 Company: Morepen Proprietary Drug Research Pvt. Ltd. (MPDRPL)
📌 Location: Gagillapur, Hyderabad.
📧 Apply at: jobs@morepenpdr.com 📞 +91 6302 451 459
About Us
Morepen Proprietary Drug Research Pvt. Ltd. (MPDRPL) is a dynamic pharmaceutical R&D organization committed to developing high-quality, affordable generic and novel products for global markets. With a focus on innovation and regulatory compliance, we work in the area of ANDA, NCEs, 50b2, API development and novel polymorphs.
Job Roles & Responsibilities
Development QA Responsibilities
• Provide Development QA support for API R&D and development activities, including laboratory and pilot-scale operations.
• Handle Drug Master File (DMF) preparation, review, and filing (USDMF, CEP, and other regulatory submissions).
• Review and approve development protocols, reports, specifications, and validation documents.
• Ensure compliance with ICH guidelines, cGMP, and global regulatory standards during API development.
• Review and manage deviations, change controls, OOS/OOT, and CAPA related to development activities.
• Provide QA oversight during technology transfer from R&D to Manufacturing.
• Ensure data integrity (ALCOA+), documentation accuracy, and SOP compliance in R&D laboratories.
• Coordinate with R&D, Regulatory Affairs, Analytical R&D, and Manufacturing teams.
• Support and participate in internal audits, vendor audits, and regulatory inspections.
Regulatory & Compliance
• Ensure adherence to cGMP, ICH, and Data Integrity requirements.
• Support preparation and review of QA sections for DMF and regulatory filings.
• Assist in responding to regulatory observations and inspection queries.
Knowledge & Experience
· M.Sc. with relevant experience in API Development QA.
· Qualification: M.Sc in Chemistry / Pharmaceutical Sciences (or related disciplines)
· 6-10 years of experience in Pharmaceutical Quality Assurance.
· Good verbal and written communication skills in English.
· Experience in Internal / Vendor audits (preferable)
· Hands-on experience in API R&D / Development QA (mandatory).
· Experience from an API R&D environment preferred (Process R&D / AR&D / development functions)
· Strong knowledge of ICH guidelines and regulatory expectations.
· Proven experience in DMF filing and regulatory documentation.
· Good audit skills (internal, external, and regulatory audits).
· Strong documentation, communication, and analytical skills.
Key Competencies
· Regulatory Compliance & Quality Mindset
· Good systems thinking mindset
· Exposure to GMP quality systems
· QA professionals from API manufacturing environment with similar skill sets are also welcome.
· Analytical Thinking & Problem Solving
· Cross-functional Coordination
· Audit & Inspection Readiness
· Attention to Detail & Data Integrity Focus
Why Join MPDRPL?
- Be part of an organization driving cost-effective global healthcare solutions.
- Work on end-to-end projects from concept to market.
- Collaborate with experts across departments in a quality-driven, innovation-centric environment.
- Access to modern formulation laboratories and pilot-scale facilities.
- Competitive compensation with performance-linked incentives.
- Professional development and career advancement opportunities.
- Comprehensive employee benefits including healthcare and retirement plans.
Application Process
To apply, submit your updated CV and a cover letter highlighting your relevant experience to:
📧 jobs@morepenpdr.com
MPDRPL is an equal opportunity employer committed to a diverse and inclusive workplace.
Click on Apply to know more.