Assistant Manager

Cadila Pharmaceuticals Limited; Mumbai; On-site; INR 1,800,000 - 2,800,000; Full time

Job summary

Cadila Pharmaceuticals Limited is seeking an experienced QC Supervisor / Assistant Manager to oversee API QC in a manufacturing facility. The role covers lab operations, planning, team leadership, instrument troubleshooting, and investigations into quality incidents.

The candidate should have 8–10 years in pharmaceutical QC, hands-on HPLC/GC troubleshooting, and a strong grasp of GMP, QMS, data integrity, and regulatory requirements.

Qualifications

• 8–10 years of experience in pharmaceutical Quality Control, with API QC exposure.
• Hands-on experience in work planning, supervision of QC labs, and team handling.
• Strong knowledge of GMP, data integrity, and regulatory compliance.
• Experience with OOS/OOT investigations and root-cause analysis.
• Familiarity with QMS and deviation management.

Responsibilities

• Oversee QC activities in an API manufacturing facility and ensure timely testing and documentation.
• Plan, prioritize, and allocate daily QC tasks; supervise analysts and training.
• Troubleshoot HPLC and GC instruments; coordinate maintenance and calibration.
• Ensure QMS compliance, data integrity, and complete deviation/CAPA processes.
• Drive investigations into OOS and OOT results with scientific justification and timelines.
• Support internal and regulatory audits and continuous improvement initiatives.

Skills

Work planning

Team supervision

HPLC troubleshooting

GC troubleshooting

Leadership

Communication

Education

M.Sc. in Chemistry

Job description

We are seeking an experienced QC Supervisor / Assistant Manager to oversee Quality
Control activities in an Active Pharmaceutical Ingredient (API) manufacturing facility. The
candidate will be responsible for laboratory operations, work planning, team management,
analytical instrument troubleshooting, investigation of quality incidents, and compliance with
regulatory and quality standards.

Key Responsibilities

1. QC Operations and Work Planning
   Plan, prioritize, and allocate daily QC activities among team members based on
   production requirements and sample priorities.
   Supervise routine analysis of raw materials, intermediates, in-process samples,
   finished APIs, and stability samples, as applicable.
   Ensure timely completion of analytical testing, documentation, and reporting.
   Monitor laboratory workload, turnaround time, and team performance.
   Ensure availability and proper utilization of laboratory instruments, chemicals,
   reagents, and reference standards.
2. Team Handling and Supervision
   Lead, guide, and supervise QC analysts and laboratory personnel.
   Assign responsibilities, monitor performance, and ensure adherence to approved
   SOPs.
   Provide training on analytical methods, laboratory safety, GMP practices, and
   documentation requirements.
   Coordinate with Production, QA, R&D, and other relevant departments to resolve
   quality-related issues.
   Ensure effective shift planning and resource utilization, where applicable.
3. HPLC/GC Troubleshooting
   Troubleshoot analytical instrument issues related to HPLC and GC systems.
   Identify potential causes of analytical failures, abnormal chromatograms, system
   suitability failures, and instrument performance issues.
   Coordinate with instrument service engineers and relevant teams for corrective
   maintenance, as required.
   Ensure proper instrument calibration, qualification, maintenance, and usage
   documentation.
   Support method troubleshooting and ensure reliable, reproducible analytical results.
4. Quality Management System (QMS)
   Ensure compliance with applicable GMP requirements, approved SOPs, and internal
   quality procedures.
   Review and maintain QC records, analytical data, laboratory logbooks, and test
   reports.
   Participate in deviation management, CAPA, change control, and other QMS
   activities.
   Ensure adherence to data integrity principles and good documentation practices.
   Support internal audits, customer audits, and regulatory inspections.
5. OOS/OOT Investigation and Incident Management
   Lead or support investigations into Out-of-Specification (OOS) and Out-of-Trend
   (OOT) results.
   Investigate analytical discrepancies, laboratory incidents, and unexpected test results.
   Perform systematic root cause analysis and recommend appropriate corrective and
   preventive actions.
   Ensure investigations are scientifically justified, properly documented, and completed
   within defined timelines.
   Track CAPA implementation and verify effectiveness, as applicable.
6. Compliance and Continuous Improvement
   Ensure QC activities comply with applicable GMP, GLP, pharmacopoeial, and
   regulatory requirements.
   Identify opportunities to improve laboratory efficiency, analytical reliability, and
   documentation quality.
   Maintain laboratory housekeeping, safety, and compliance standards.
   Support continuous improvement initiatives within the API QC laboratory.

Mandatory Requirements

• Qualification: M.Sc. in Chemistry.
• Experience: 8–10 years in pharmaceutical Quality Control, with mandatory API QC
• experience.
• Proven experience in work planning, laboratory supervision, and team handling.
• Hands-on knowledge of HPLC and GC troubleshooting.
• Strong understanding of QMS and pharmaceutical quality systems.
• Experience in OOS/OOT investigations and root cause analysis.
• Good knowledge of GMP, laboratory documentation, data integrity, and regulatory
• compliance.

Preferred Skills

• Experience in API manufacturing and analytical testing of pharmaceutical
• intermediates and finished APIs.
• Knowledge of analytical method validation and method transfer.
• Familiarity with CAPA, deviations, change control, and risk assessment.
• Strong leadership, problem-solving, communication, and decision-making skills.

Parameter Requirement

• Job Title QC Supervisor / Assistant Manager
• Department API Quality Control
• Qualification M.Sc. Chemistry
• Experience 8–10 Years
• Vacancies 1
• Mandatory Experience API QC
• Technical Skills HPLC/GC troubleshooting
• Quality Systems QMS, OOS/OOT investigations
• Leadership Skills Work planning and team handling