A seasoned pharmaceutical professional with over 12 years of comprehensive experience in
Research & Development (R&D), Production, Quality Control (QC), and Quality Assurance (QA)
for
intermediates and API manufacturing
. Responsible for ensuring smooth operation of all plant functions, driving innovation, and ensuring adherence to quality, safety, and compliance standards.
Key Responsibilities:1. Research & Development (R&D):
Lead development of new intermediates and API processes with focus on yield improvement, cost reduction, and scalability.
Implement and validate process optimization strategies.
Collaborate with analytical R&D for method development and validation.
Conduct feasibility studies and pilot trials for new products.
2. Production:
Plan, execute, and supervise daily manufacturing activities.
Monitor batch manufacturing records (BMRs) and ensure compliance with cGMP.
Ensure smooth coordination between planning, maintenance, and production teams.
Troubleshoot process deviations and resolve operational issues effectively.
Maintain productivity targets while minimizing downtime and wastage.
3. Quality Control (QC):
Supervise QC operations including raw material, in-process, and finished product testing.
Ensure timely release of materials with validated analytical methods.
Monitor stability studies and calibration of analytical instruments (HPLC, GC, etc.).
Review COAs and ensure analytical compliance with regulatory specifications.
4. Quality Assurance (QA):
Ensure cGMP, GLP, and regulatory compliance across departments.
Handle documentation: SOPs, BMRs, deviations, change controls, CAPA, etc.
Coordinate internal and external audits (regulatory, customer, ISO, etc.).
Conduct training sessions for personnel on quality systems and regulatory expectations.
5. Plant Operations & Compliance:
Manage cross-functional teams to ensure smooth operations.
Maintain EHS (Environment, Health, Safety) standards as per statutory norms.
Participate in technology transfer and scale-up projects.
Liaise with regulatory agencies for documentation and licensing support.
Skills & Competencies:
Deep knowledge of API/intermediate manufacturing processes.
Strong understanding of regulatory guidelines: ICH, USFDA, WHO-GMP, EUGMP.
Leadership and team management skills.
Proficiency in documentation, problem-solving, and audit handling.
Familiarity with QMS tools and digital documentation systems.
Technical Expertise:
Process chemistry and scale-up
cGMP, QMS, GLP, EHS standards
Analytical instruments: HPLC, GC, UV, IR
Documentation: SOPs, BMR/BPR, STP, COA
Regulatory audit preparedness
Education:
B.Sc. / M.Sc. in Chemistry / Organic Chemistry / Pharmaceutical Sciences
or
B.Tech / M.Tech in Chemical Engineering / Pharma Technology
Job Type: Full-time
Pay: ?75,000.00 - ?80,000.00 per month
Benefits:
Food provided
Health insurance
Provident Fund
Ability to commute/relocate:
Raichur, Karnataka: Reliably commute or planning to relocate before starting work (Required)
Education: