Quality Head

Job Title: Head of Quality API Manufacturing (QA & QC)

Location: Padra Loction

Experience Required: 20–22 Years

Department: Quality Assurance & Quality Control

Employment Type: Full-Time

Role Summary:

The Head of Quality will lead the Quality Assurance and Quality Control functions for the API manufacturing facility, ensuring full compliance with global regulatory standards (USFDA, EUGMP, WHO, etc.). This role demands strategic oversight, technical depth, and operational excellence in managing quality systems, laboratory operations, audits, and regulatory submissions.

Key Responsibilities:

Quality Assurance (QA):

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- Lead internal audits, vendor qualification, and regulatory inspections.

- Approve master documents including SOPs, validation protocols, and batch records.

- Drive CAPA, change control, deviation, and risk management programs.

- Ensure data integrity and compliance across all documentation and systems.

Quality Control (QC):

- Supervise analytical testing of raw materials, intermediates, and finished APIs.

- Ensure timely release of batches and stability studies.

- Monitor calibration and qualification of laboratory instruments (HPLC, GC, etc.).

- Review and approve analytical method validations and transfers.

- Implement robust OOS/OOT investigation protocols.

Strategic & Leadership Duties:

- Mentor and develop QA/QC teams; foster a culture of continuous improvement.

- Collaborate with cross-functional teams (Production, R&D, Regulatory Affairs).

- Lead quality metrics reporting and present to senior management.

- Stay updated with evolving regulatory guidelines and industry best practices

Required Skills & Competencies:

| Regulatory Knowledge | Deep understanding of USFDA, EUGMP, ICH, WHO-GMP guidelines |

| Technical Expertise | Strong command over analytical techniques, validation, and documentation |

| Leadership | Proven ability to lead large teams and manage cross-functional collaboration |

| Problem Solving | Skilled in root cause analysis and implementing effective CAPAs |

| Communication | Clear and assertive communicator with strong documentation skills |

Qualifications:

- M.Pharm / M.Sc. / B.Pharm with specialization in Pharmaceutical Chemistry or related field.

- Minimum 20 years of experience in QA/QC within API manufacturing.

- Prior experience in handling regulatory inspections (USFDA, EUGMP, etc.) is mandatory.

Preferred Attributes:

- Six Sigma or Lean Quality certification.

- Experience in setting up or scaling quality systems in greenfield/brownfield projects.

- Exposure to digital QMS platforms