Assistant General Manager Quality Assurance

Adler Talent Solutions Pvt Ltd; Tanuku; Vor Ort; INR 2.500.000 - 4.200.000; Vollzeit

Zusammenfassung

Adler Talent Solutions Pvt Ltd in India is seeking an experienced AGM Quality Assurance to lead QA operations at an API manufacturing plant. The role focuses on ensuring GMP compliance, managing QMS, audits, and documentation while building a high-performing QA team.

The ideal candidate has deep experience in regulatory inspections (USFDA/WHO-GMP/EU-GMP), CAPA, validation, risk assessment, and data integrity, and will drive continuous improvement across production, quality control, regulatory

Qualifikationen

• Extensive experience in pharmaceutical API manufacturing quality systems.
• Proven knowledge of GMP/cGMP guidelines and regulatory expectations.
• Experience with regulatory inspections and customer audits.
• Strong risk assessment, deviation handling, CAPA and change control expertise.
• Leadership skills with ability to mentor QA team.

Aufgaben

• Lead QA activities at API manufacturing facility ensuring GMP compliance.
• Establish and maintain QMS aligned with GMP and ICH guidelines.
• Oversee batch records, deviations, CAPA, change controls and investigations.
• Coordinate internal and external audits and regulatory inspections.
• Ensure SOPs and documentation practices across functions.
• Develop QA team and drive continuous improvement.

Kenntnisse

API manufacturing

Quality Assurance

Regulatory compliance

cGMP

QMS

Audits

CAPA

Deviation handling

Data integrity

Jobbeschreibung

Role & responsibilities

We are looking for an experienced and dynamic AGM Quality Assurance to lead and manage QA operations at an API manufacturing plant. The ideal candidate should have extensive experience in pharmaceutical API manufacturing, regulatory compliance, quality management systems, audits, documentation, and team leadership. The candidate will be responsible for ensuring compliance with applicable GMP guidelines, regulatory requirements, and company quality standards.

Key Responsibilities

• Lead and manage all Quality Assurance activities at the API manufacturing facility, ensuring compliance with applicable regulatory requirements and cGMP guidelines.
• Establish, implement, and maintain the Quality Management System (QMS) in line with applicable GMP, ICH guidelines, and regulatory expectations.
• Oversee batch manufacturing records, batch release documentation, deviations, CAPA, change controls, and investigations.
• Ensure effective implementation of SOPs, quality policies, and documentation practices across manufacturing and quality functions.
• Manage internal audits, external audits, customer audits, and regulatory inspections, including preparation, coordination, and closure of observations.
• Handle regulatory compliance requirements related to applicable authorities such as USFDA, WHO-GMP, EU-GMP, and other relevant regulatory bodies, as applicable to the facility.
• Review and approve validation protocols and reports, including process validation, cleaning validation, equipment qualification, and computerized system validation, as applicable.
• Oversee the management of out-of-specification (OOS), out-of-trend (OOT), deviations, non-conformances, and quality-related investigations.
• Ensure effective implementation of risk management, data integrity, document control, and continuous improvement initiatives.
• Coordinate with Production, Quality Control, Regulatory Affairs, Engineering, and other departments to resolve quality-related issues.
• Monitor product quality, process compliance, and trends to identify risks and implement preventive measures.
• Ensure timely preparation and review of annual product quality reviews (APQR/PQR), where applicable.
• Lead customer complaint investigations, product quality assessments, and implementation of corrective and preventive actions.
• Develop, mentor, and manage the QA team, ensuring competency development, training, and performance management.
• Drive a culture of quality, compliance, accountability, and continuous improvement throughout the plant.

Preferred candidate profile

Required Skills & Competencies

• Strong knowledge of pharmaceutical API manufacturing processes and quality assurance systems.
• Expertise in cGMP, QMS, regulatory compliance, and pharmaceutical quality documentation.
• Experience in handling regulatory inspections and customer audits.
• Strong understanding of deviations, CAPA, change control, validation, risk assessment, and data integrity.
• Proven team management, leadership, and cross-functional coordination skills.
• Strong analytical, problem-solving, decision-making, and communication abilities.
• Ability to lead quality initiatives and ensure inspection readiness at the manufacturing facility.