Manager - Quality Assurance

RESPONSIBILITIES:

1. Quality Leadership & Compliance

• Lead the Quality Assurance department and ensure compliance with GMP, regulatory guidelines, and company policies.
  
• Implement, monitor, and continuously improve quality systems across the organization.
  
• Oversee documentation control and ensure data integrity in all QA processes.
  

2. Quality Oversight & Decision-Making

• Oversee and approve critical quality documents (such as master SOPs, batch release records, change controls, deviations, and CAPA) while ensuring effective review by the QA team.
  
• Ensure timely closure of investigations related to deviations, OOS, and complaints, with effective corrective and preventive actions.
  
• Authorize batch release in line with regulatory and company requirements.
  
• Ensure qualification and validation of equipment, utilities, and manufacturing processes as per regulatory expectations.
  

3. Audits & Regulatory Inspections

• Conduct internal audits and ensure site readiness for external audits (regulatory and customer).
  
• Act as the primary point of contact during inspections by regulatory authorities and clients.
  

4. Team Management & Development

• Guide, train, and develop the QA team to strengthen compliance and quality culture.
  
• Allocate responsibilities within the QA department and monitor performance.
  

5. Cross-Functional Collaboration

• Collaborate with Production, QC, Engineering, and other departments to resolve quality-related issues.
  

6. Continuous Improvement

• Drive initiatives across the plant to enhance quality systems, compliance, and overall quality culture.

REQUIRED SKILLS AND KNOWLEDGE:

Bachelors/Masters degree in Pharmacy, Chemistry, or related field.

• Minimum 13+ years of experience in Quality Assurance, with at least 5 years in a leadership role in the pharmaceutical industry (API).
  
• Strong knowledge of GMP, ICH, WHO, USFDA, MHRA, and other regulatory guidelines.
  
• Proven experience in facing regulatory inspections and handling audits.
  
• Expertise in change control, deviation, CAPA, OOS investigations, and batch release.
  
• Excellent leadership and people management skills.
  
• Strong documentation control and data integrity orientation.
  
• Good communication skills with proficiency in English (written and spoken).
  
• Knowledge of Telugu and Hindi preferred for better coordination with cross-functional teams.
  

HOW TO APPLY:

• Email resume to [email removed] (subject: Application - QA Head - Kazipally/Bonthapally).

• Talent Acquisition team will screen resumes and contact shortlisted candidates for an initial interview via telephonic.

• Candidates shortlisted after the initial round will be scheduled for further interviews with the Corporate QA Head, Plant Head, and/or Management (if required)

• Please carry original ID and educational/professional documents when called for in-person interview.

Note: For any information before applying, or to track your application/recruitment status, you may contact Mr. V. Prasant (HR) at [phone removed] / [phone removed].