DGM-Quality Control

Role & responsibilities

1. Quality Control Oversight & Strategy:

• Develop and implement QC strategies to ensure that the parenteral products meet regulatory requirements (e.g., FDA, EMA, WHO) and company specifications.
• Ensure that all quality control processes are aligned with the company's overall quality assurance strategy and objectives.
• Establish and monitor quality metrics for the performance of QC operations.

2. Testing & Analysis Management:

• Oversee the testing of raw materials, in-process materials, finished products, and stability studies for parenteral drug products.
• Ensure appropriate and rigorous testing of both physical and chemical properties (e.g., sterility, endotoxins, particulate matter, potency, and pyrogen testing).
• Manage analytical method development, validation, and transfer for parenteral products.
• Ensure that all testing is conducted in accordance with approved Standard Operating Procedures (SOPs) and Good Laboratory Practices (GLP).

3. Compliance & Regulatory Affairs:

• Ensure that all QC processes comply with local and international regulatory requirements, such as Good Manufacturing Practices (GMP), Good Laboratory Practices (GLP), and ISO standards.
• Coordinate with regulatory authorities and internal teams to ensure timely preparation and submission of regulatory filings (e.g., INDs, NDAs).
• Oversee audits (both internal and external), and work closely with regulatory agencies during inspections.
• Stay updated on changes in regulatory guidelines affecting parenteral product manufacturing and testing.

4. Team Leadership & Staff Development:

• Lead, manage, and train the QC team, ensuring that they are equipped with the skills and knowledge necessary for the effective testing and release of parenteral products.
• Set performance goals for the team and conduct regular performance evaluations.
• Foster a culture of continuous improvement and quality awareness within the QC department.

5. Quality System Management:

• Ensure the implementation and maintenance of an effective Quality Management System (QMS) within the QC department.
• Manage the deviation, investigation, and CAPA (Corrective and Preventive Action) processes for quality-related issues.
• Oversee the change control process related to QC and product testing.
• Manage and review product release and reject decisions, ensuring that any out-of-specification (OOS) results are thoroughly investigated.

6. Instrument and Equipment Management:

• Ensure the calibration, qualification, and maintenance of laboratory instruments and testing equipment used in the QC lab.
• Work with other departments to ensure that all equipment is validated and operating within specified limits.
• Oversee the validation of new equipment and technologies in QC testing.

7. Documentation & Reporting:

• Ensure that all QC testing documentation is accurate, complete, and compliant with regulatory standards.
• Prepare and review quality control reports, including testing data, trending analyses, and risk assessments.
• Provide regular updates and reports to senior management on QC activities, product quality, and regulatory compliance status.

8. Risk Management & Continuous Improvement:

• Identify potential quality risks associated with parenteral drug manufacturing processes and develop risk mitigation strategies.
• Lead continuous improvement initiatives to enhance the efficiency, reliability, and robustness of QC operations, such as introducing new analytical techniques or optimizing existing processes.
• Manage investigations related to product complaints, recalls, and non-conformance, ensuring that they are handled efficiently and in compliance with regulatory requirements.

9. Supply Chain Coordination:

• Coordinate with other departments (e.g., Manufacturing, Supply Chain, and R&D) to ensure smooth product release and shipment timelines.
• Work closely with manufacturing to ensure raw materials, intermediate, and final products meet required QC standards before release.

Preferred candidate profile

Perks and benefits