Executive Quality Assurance / Regulatory Affairs

Department:

Reports To:

Location:

Job Summary:

The Quality Control Specialist in a pharmaceutical company is responsible for ensuring that all products meet quality standards and regulatory requirements before they are released to the market. This role involves performing a variety of testing and analysis procedures on raw materials, in-process materials, and finished products. The Quality Control Specialist works closely with the production team to identify and resolve quality issues and contributes to the continuous improvement of quality systems and processes.

Key Responsibilities:

• Conduct routine and non-routine testing of raw materials, in-process samples, and finished products using various analytical techniques (e.g., HPLC, GC, UV/VIS spectroscopy).
• Perform microbiological testing, stability testing, and environmental monitoring as required.
• Record and analyze test results to ensure products meet specified standards and comply with regulatory requirements.
• Maintain accurate and detailed records of all tests, analyses, and inspections in accordance with Good Documentation Practices (GDP).
• Ensure all testing procedures and results comply with Good Manufacturing Practices (GMP), FDA regulations, and other relevant guidelines.
• Prepare and review Certificates of Analysis (COAs) and other quality-related documentation.
• Identify deviations from standard specifications and investigate the root causes of quality issues.
• Collaborate with the production, research and development, and quality assurance teams to implement corrective and preventive actions (CAPAs).
• Participate in the review and approval of production batch records and quality investigations.
• Assist in the development and validation of new analytical methods and procedures.
• Participate in internal audits and inspections to ensure compliance with internal quality systems and regulatory standards.
• Recommend and implement continuous improvements to enhance product quality and efficiency.
• Train and mentor junior quality control staff on testing procedures, equipment operation, and quality standards.
• Stay current with industry trends, regulatory updates, and advancements in analytical techniques.

Qualifications:

• Education:

  Bachelor's degree in Chemistry, Microbiology, Pharmaceutical Sciences, or a related field. Advanced degree preferred.

• Experience:

  Minimum of 2-5 years of experience in quality control within the pharmaceutical industry.

• Technical Skills:

  Proficiency in analytical techniques such as HPLC, GC, FTIR, and spectrophotometry. Familiarity with GMP, GDP, and regulatory requirements (e.g., FDA, EMA).

• Soft Skills:

  Strong attention to detail, excellent problem-solving skills, and the ability to work collaboratively in a team environment.

• Certifications:

  Relevant certifications (e.g., Certified Quality Auditor, Six Sigma) are a plus.