Quality Assurance Officer

Role & responsibilities

• Developing and Implementing Quality Standards:

  This involves creating and maintaining documentation like standard operating procedures (SOPs) and work instructions, ensuring they are up-to-date and aligned with relevant regulations and industry best practices.

• Conducting Quality Audits:

  QA officers plan and execute both internal and external audits to assess compliance with established quality standards and identify areas for improvement.

• Performing Inspections and Tests:

  They oversee product inspections at various stages of production, ensuring they meet quality requirements, and document any deviations.

• Investigating Quality Issues:

  When quality problems arise, QA officers investigate the root cause, recommend corrective actions, and track their implementation to prevent recurrence.

• Managing Documentation and Reporting:

  This includes maintaining accurate records of quality-related activities, generating reports on quality metrics, and communicating findings to relevant stakeholders.

• Driving Continuous Improvement:

  QA officers analyze quality data, identify trends, and implement strategies to improve processes and products, often utilizing methodologies like Six Sigma or lean manufacturing.

• Ensuring Compliance:

  QA officers ensure adherence to all relevant regulations, standards, and legal requirements related to product quality and safety.

• Training and Education:

  They may be involved in training employees on quality control procedures and best practices.

• Risk Management:

  QA officers play a role in identifying potential risks associated with product quality and developing mitigation strategies.
• Execute and review Equipment Qualification protocols (IQ, OQ, PQ) in compliance with regulatory requirements.
• Prepare, execute, and review Cleaning Validation protocols and reports.
• Participate in the design, execution, and documentation of Computer System Validation (CSV) as per GMP 5 guidelines.
• Coordinate and support Process Validation activities, including preparation and review of protocols, execution, and final reporting.
• Ensure that all validation activities are compliant with GMP, regulatory guidelines, and internal SOPs.
• Perform gap assessments, risk assessments, and deviation handling related to validation.
• Collaborate with cross-functional teams including production, engineering, QC, and IT for validation planning and execution.
• Assist in internal audits, regulatory inspections, and prepare responses to audit observations.

Maintain and update validation master plans and SOPs regularly

Preferred candidate profile

• Bachelor's or Master's degree in Chemistry, Chemical Engineering, or related field.
• Knowledge of GMP, GLP, and other relevant regulations.

• Relevant Experience:

  Experience in quality control within the chemical industry, or a related field (e.g., pharmaceuticals), is highly desirable.

• Specific Skills:

  Knowledge of laboratory operations, chemical analysis techniques (including HPLC), and relevant safety standards is essential.

• Familiarity with Regulations:

• Strong analytical, problem-solving, and decision-making skills.
• Excellent communication and interpersonal skills.
• Proficiency in documentation and record-keeping.
• Experience in pharmaceutical or chemical manufacturing is preferred.