Hiring for Manager DQA | Gurugram

We are looking for an individual for the Quality Assurance team to review and revise SOPs, oversee document control in product development, and conduct risk assessments. Responsibilities include reviewing Specifications and STPs, ensuring data integrity, MFC, MPC, Proposing QbD (Quality by Design) process changes, and participating in phase gate reviews.

A. Key Accountabilities

- Responsible to ensure development practices align with current regulatory expectations
- Responsible for establishing and maintaining comprehensive quality management systems (QMS).
- Responsible for preparation and control of SOPs, MFC, MPC, Protocol, report, and batch records
- Responsible to review and approve specifications and Standard Testing Protocols (STPs) for various materials at different development stages, ensuring compliance with guidelines and SOPs during all stages of development and technology transfer.
- Responsible to conduct conducts risk assessments to proactively identify and address potential quality risks during product development.
- Confirming that test methods are suitable for their intended use (specificity, accuracy, precision, etc.)
- Responsible to conduct internal audits of R&D; and development labs
- Responsible for Performing vendor qualification audits for raw material suppliers, CROs, etc.




- Implementing audit findings and follow-up actions
- To support submission of dossiers (e.g., CTD modules) with proper validation and quality documentation
- Responsible for ensuring compliance in development laboratories, reviewing and approving facility/equipment qualifications and managing Quality notifications such as incidents.

Any other additional responsibility could be assigned to the role holder from time to time as a standalone project or regular work. The same would be suitably represented in the Primary responsibilities and agreed between the incumbent, reporting officer and HR.

B. Skills & Capabilities

- Thorough understanding and practical application of regulatory requirements in pharmaceutical development.
- Proficient in implementing Quality by Design (QbD) principles in the product development process.
- Experience in reviewing, revising, and managing SOPs in alignment with industry standards.

Expertise in conducting, reviewing, and approving risk assessments throughout the product development lifecycle.

C. Educational and Experience Requirements

MSc in Organic Chemistry

10-15 years of experience Development Quality of pharmaceutical R&D;

You may share the CV [email protected]

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📌 Hiring For Manager DQA_ Gurugram
🏢 Apeejay Stya Group
📍 Gurugram