M. Pharm Pharmaceutical Quality Assurance

The program is designed to equip students with comprehensive knowledge of quality assurance practices and regulatory standards. It emphasizes the principles of Good Manufacturing Practices (GMP), quality control, and validation processes required to meet the stringent quality regulations in the pharmaceutical industry.

• • High demand for quality assurance professionals due to strict global regulations in pharmaceutical manufacturing.
  • Job opportunities in pharmaceutical, biotechnology, and medical device industries.
  • Ability to work as regulatory professionals in global markets, including roles in clinical trials, production, and documentation management.

The M. Pharm programs are structured over a two-year period, consisting of four semesters. The course involves a mix of:

• Classroom-based theoretical learning
• Laboratory-based practical sessions
• A comprehensive research project in 3^rd and 4^th Semester.

 

List of Subjects

• M. Pharm in Pharmaceutical Quality Assurance:
  • Modern Pharmaceutical Analytical Techniques
  • Quality Management Systems
  • Pharmaceutical Validation
  • Audits and Regulatory Compliance
  • Quality Risk Management
  • GMP and GLP Regulations
  • Research Methodology

• Internal Assessments (IA): Continuous assessments through assignments, practicals, and mid-term exams contribute to the final grade.
• End-Semester Exams: At the end of each semester, covering theoretical and practical subjects.
• Research Project Evaluation: Students will submit a thesis and present their research findings, which will be evaluated by an external panel of experts.
• Viva-Voce: Students undergo a final viva based on their research projects, contributing to the final semester grade.

Semester	Internal Assessment (Marks)	Semester-End Exam (Marks)	Total Marks
Semester I & II
Theory	25	75	100
Practical	50	100	150
Seminar/Assignment	—	—	100
Semester III
Theory	25	75	100
Journal Club	25	—	25
Proposal Presentation	50	—	50
Research Work*	—	350	350
Semester IV
Journal Club	25	—	25
Final Presentation	75	—	75
Research Work and Colloquium	—	400	400
Research Work Project (Sem III & IV)
Dissertation Book	—	—	500
Presentation	—	—	250

• • Master the application of analytical methods to ensure pharmaceutical product safety and efficacy.
  • Develop the skills to implement and manage Quality by Design (QbD) in pharmaceutical production.
  • Gain knowledge of the latest developments in regulatory frameworks such as USFDA, EMA, and ICH guidelines.
  • Proficiency in quality risk management and compliance for pharmaceutical audits and certifications.

• • Leadership roles in Quality Assurance (QA) and Quality Control (QC) departments.
  • Careers in regulatory affairs, working with agencies like the FDA, MHRA, and WHO.
  • Roles as GMP auditors, focusing on compliance with international quality standards.
  • Validation and process control experts in pharmaceutical manufacturing plants.

M. Pharm in Pharmaceutics and Pharmaceutical Quality Assurance are highly sought after by leading pharmaceutical companies, contract research organizations (CROs), regulatory agencies, and academic institutions. Below are some potential recruiters:

Pharmaceutical Companies:

• Cipla
• Dr. Reddy’s Laboratories
• Sun Pharma
• Lupin Pharmaceuticals
• Glenmark Pharmaceuticals
• Zydus Cadila
• Aurobindo Pharma
• Torrent Pharmaceuticals
• Biocon
• Pfizer
• Abbott Laboratories
• Novartis
• Sanofi
• GlaxoSmithKline (GSK)

 

Contract Research Organizations (CROs):

• Syngene International
• IQVIA
• Veeda Clinical Research
• Lambda Therapeutic Research
• Cliantha Research
• Jubilant Life Sciences

Biotechnology Companies:

• Serum Institute of India
• Biocon
• Intas Biopharmaceuticals
• Reliance Life Sciences
• Shantha Biotechnics

Regulatory Agencies and Institutions:

• Central Drugs Standard Control Organization (CDSCO)
• Pharmaceutical Export Promotion Council (Pharmexcil)
• Indian Pharmacopoeia Commission (IPC)
• World Health Organization (WHO)
• Food and Drug Administration (FDA)
• European Medicines Agency (EMA)

Academic and Research Institutions:

• National Institutes of Pharmaceutical Education and Research (NIPER)
• Institute of Chemical Technology (ICT)
• Pharmaceutical and biotechnology universities and colleges

Other Potential Employers:

• Wockhardt
• Johnson & Johnson
• Baxter Healthcare
• Ranbaxy Laboratories
• Piramal Healthcare
• Mylan Laboratories
• Alkem Laboratories

Job Roles after Completion

• M. Pharm in Pharmaceutical Quality Assurance:
  • Quality Assurance Manager: Ensure products meet quality and safety standards before release.
  • Validation Engineer: Specialize in the validation of processes and equipment to comply with regulatory standards.
  • GMP Auditor: Conduct audits to ensure pharmaceutical companies adhere to Good Manufacturing Practices.
  • Compliance Officer: Ensure that the manufacturing and production processes comply with legal standards and regulations.