Officer/Sr. Officer/Executive – Quality Assurance

Key Responsibilities:

Quality Management System (QMS) Development and Maintenance:

1. Develop, implement, and maintain a robust quality management system (QMS) in accordance with regulatory requirements such as FDA, EMA, and other applicable standards.
2. Establish and maintain quality assurance procedures, policies, and documentation, including SOPs (Standard Operating Procedures), work instructions, and quality records.

Regulatory Compliance:

1. Ensure compliance with all relevant regulatory requirements, guidelines, and standards governing pharmaceutical manufacturing, distribution, and quality assurance.
2. Stay current with changes in regulations and industry best practices, implementing necessary updates to maintain compliance.

Audits and Inspections:

1. Plan, coordinate, and conduct internal audits to assess compliance with quality standards, procedures, and regulations.
2. Prepare for and participate in external audits and regulatory inspections, addressing findings and implementing corrective actions as necessary.

Quality Control

1. Oversee quality control activities, including raw material testing, in-process testing, and finished product testing, to ensure compliance with specifications and standards.
2. Monitor and analyze quality metrics and trends, identifying areas for improvement and implementing corrective and preventive actions (CAPAs).

Documentation and Record Keeping:

1. Manage the documentation and record-keeping processes related to quality assurance activities, ensuring accuracy, completeness, and traceability of records.
2. Maintain a document control system to manage revisions, approvals, and distribution of quality documents.

Training and Development:

1. Provide training and guidance to employees on quality assurance procedures, regulations, and best practices.
2. Foster a culture of quality and continuous improvement by promoting awareness and understanding of quality principles throughout the organization.

Supplier and Vendor Management:

1. Establish and maintain quality agreements with suppliers and vendors, ensuring that materials and services meet quality requirements.
2. Conduct supplier audits and assessments to evaluate compliance and performance, addressing any non-conformities identified.

Continuous Improvement:

1. Lead and support quality improvement initiatives and projects to enhance processes, products, and systems.
2. Utilize quality tools and techniques such as root cause analysis, statistical process control, and risk management to drive continuous improvement.

Qualifications:

Education: Bachelor’s or Master’s in a relevant field such as Pharmacy, Chemistry, Biology,

Experience:

For Manager role: 5+ years of experience in quality assurance or quality management within the pharmaceutical industry, including experience with regulatory compliance.