Key Responsibilities

1. Strategic Quality Leadership & Compliance

- Formulate, implement, and continuously improve the site's Quality Management System (QMS) in line with standard regulatory guidelines.
- Oversee site preparation for statutory, regulatory, and customer audits; act as the primary point of contact during inspections.
- Lead CAPA (Corrective and Preventive Action) programs, root-cause analyses, Out-of-Specification (OOS), Out-of-Trend (OOT), and deviation investigations.
- Maintain complete compliance with state FDA regulations, regulatory filings, and licensing requirements.

2. Quality Assurance (QA) Operations

- Final authority on batch records review, batch release, and product disposition.
- Oversee document control: creation, modification, and enforcement of SOPs, BMR/BPR, and validation master plans (VMP).
- Ensure comprehensive vendor qualification and periodic supplier quality audits.
- Supervise validation and qualification activities across HVAC, water systems, plant equipment, and analytical methods.

3. Quality Control (QC) Operations

- Manage testing operations for Raw Materials (RM), Packing Materials (PM), in-process samples, finished products, and stability samples.
- Enforce strict GLP (Good Laboratory Practices) and ensure 100% data integrity across electronic instruments (HPLC, GC, UV-Vis, FTIR).
- Manage calibration, maintenance,



and qualification schedules for all analytical instruments.

4. Team Leadership & Resource Management

- Lead, mentor, and upskill a cross-functional team of QA and QC managers, executives, and chemists.
- Drive a site-wide culture of operational excellence, continuous training, and zero tolerance for non-compliance.

Required Qualifications & Experience

- Education:
- B.Pharm / M.Pharm / [suspicious link removed]. (Organic Chemistry, Analytical Chemistry, or relevant discipline).
- Experience:
- 8 to 15 years of progressive experience in pharmaceutical QA/QC operations.
- Minimum 3+ years in a managerial or departmental lead role overseeing both QA and QC functions.
- Demonstrated hands-on exposure to formulations manufacturing (Tablets, Capsules, Liquids, Injections, or Ointments).

Technical Skills & Competencies

- Expertise in cGMP, GLP, WHO-GMP, ICH guidelines, and regulatory requirements.
- Proven track record in handling state/national FDA inspections and customer audits.
- Proficiency in risk management (FMEA), investigation techniques (5-Whys, Fishbone), and data integrity standards.
- Strong leadership, conflict-resolution, and stakeholder management skills

Pay: ₹1,000,000.00 - ₹1,800,000.00 per year

Advantages

- Provident Fund

Work Location: In person

📌 QA and QC head (Kashipur)
🏢 Balaji Sai Placement
📍 Kashipur