Executive - QA

Drlogy; Suryapet; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Suven Life Sciences Limited, a biopharmaceutical innovator, seeks an Executive – QA to implement and maintain QMS, ensure cGMP/GLP compliance, and support validation, documentation, and regulatory processes.

You will review BMR/BPR, update SOPs, manage deviations and CAPA, conduct internal audits, ensure data integrity, participate in validation activities, monitor quality metrics, and collaborate with QC and production to sustain product quality.

Qualifications

• Experience implementing and maintaining QMS in pharma environments.
• Strong knowledge of cGMP and GLP regulatory requirements.
• Ability to review and approve batch records and other quality documents.
• Proven capability to manage deviations and CAPA.
• Experience conducting internal audits and supporting external audits.
• Ensure data integrity and proper documentation practices.

Responsibilities

• Implement and maintain Quality Management Systems (QMS).
• Review and approve batch manufacturing records (BMR) and batch packing records (BPR).
• Prepare, review, and update SOPs, protocols, and quality reports.
• Manage deviations, change controls, and CAPA processes.
• Conduct internal audits and support regulatory inspections.
• Ensure data integrity and document control across processes.
• Participate in validation and qualification activities (process, equipment, cleaning).
• Monitor quality metrics and drive continuous improvement.
• Coordinate with QC, production, and other departments.

Skills

QMS implementation

cGMP knowledge

Audits & regulatory compliance

CAPA management

Documentation control

Data integrity

Validation & qualification

Quality metrics analysis

Cross-functional collaboration

Attention to detail

Tools

BMR/BPR review

Job description

The Executive – QA will be responsible for implementing and maintaining Quality Management Systems (QMS), ensuring adherence to cGMP guidelines, and supporting validation, documentation, and compliance processes. This requires strong analytical skills, attention to detail, and a thorough understanding of pharmaceutical quality standards.

Roles and Responsibilities:

• Ensure compliance with cGMP, GLP, and regulatory requirements across operations.
• Implement and maintain Quality Management Systems (QMS).
• Review and approve batch manufacturing records (BMR), batch packing records (BPR), and other quality documents.
• Prepare, review, and update SOPs, protocols, reports, and quality-related documentation.
• Manage deviations, change controls, and CAPA (Corrective and Preventive Actions).
• Conduct internal audits and support external audits and regulatory inspections.
• Ensure proper documentation practices and data integrity as per guidelines.
• Participate in validation and qualification activities (process, equipment, cleaning, etc.).
• Monitor and review quality metrics and trends for continuous improvement.
• Handle out-of-specification (OOS) and out-of-trend (OOT) investigations.
• Coordinate with QC, production, and other departments for quality-related issues.
• Ensure proper implementation of document control systems.
• Support product release activities and ensure compliance with specifications.
• Maintain audit readiness and ensure timely closure of audit observations.
• Provide training on quality procedures, GMP practices, and compliance requirements.
• Ensure proper handling of complaints, recalls, and non-conformance issues.
• Monitor adherence to hygiene, safety, and quality standards across departments.
• Assist in regulatory submissions and documentation when required.
• Stay updated with current regulatory guidelines and industry best practices.
• Support continuous improvement initiatives in quality systems.
• Maintain confidentiality and professionalism in all QA activities.
• Collaborate with cross-functional teams to ensure product quality and compliance.
• Contribute to maintaining high standards of quality and organizational reputation.

Similar Jobs at Suven Life Sciences Limited

Suven Life Sciences Limited is a biopharmaceutical company focused on the discovery, development, and commercialization of innovative medicines. The company is particularly recognized for its research-driven approach in developing therapies for central nervous system (CNS) disorders and other critical disease areas.

Our Story

Suven Life Sciences Limited was established with a vision to advance healthcare through innovation and scientific excellence. Over the years, it has built a strong presence in drug discovery and contract research, partnering with global pharmaceutical companies while also advancing its own proprietary research pipeline.

Our Mission

• To discover and develop innovative medicines for unmet medical needs
• To deliver high-quality research and development services
• To maintain excellence in science, technology, and innovation
• To create value for patients, partners, and stakeholders

Our Vision

To be a globally recognized biopharmaceutical company driven by innovation, research excellence, and a commitment to improving patient lives.

Our Expertise / What We Do

Suven Life Sciences Limited specializes in:

• Drug discovery and development
• Research in CNS disorders and other therapeutic areas
• Contract research and manufacturing services (CRAMS)
• Development of proprietary molecules and intellectual property

Why Choose Us

• Strong focus on research and innovation
• Expertise in CNS drug discovery
• Global partnerships and collaborations
• Advanced R&D infrastructure
• Commitment to quality and regulatory compliance

Our Team

Suven Life Sciences Limited is supported by a team of experienced scientists, researchers, and professionals dedicated to advancing pharmaceutical innovation and delivering high-quality outcomes.

Infrastructure / Technology

The company operates state-of-the-art research and development facilities equipped with advanced technologies to support drug discovery and development.

Our Commitment

Suven Life Sciences Limited is committed to improving global healthcare by developing innovative and effective therapies. The company emphasizes scientific integrity, innovation, and excellence in all its operations.

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