Manager - Quality Assurance

19 hours ago

Hyderabad, Telangana, India Metrochem Full time ₹ 15,00,000 - ₹ 28,00,000 per year

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 (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 /

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