Senior QA Officer

Responsibilities

• Implement and review departmental Standard Operating Procedures (SOPs) for all production activities, ensuring compliance with internal standards and regulatory guidelines.
• Provide line clearance for production activities, ensuring all areas are prepared for the next batch and meet required standards.
• Review and approve sampling protocols for finished products, intermediates, in-process materials, stability samples, cleaning validation samples, verification samples, and reserve samples as per defined protocols.
• Approve packaging materials specimens to be attached with Packaging Order Instructions (POIs) and ensure they meet compliance standards.
• Check manufacturing and packaging POIs in the production area to ensure compliance with quality standards and regulatory requirements.
• Inspect finished goods and authorize their release for dispatch or recommend rejection based on adherence to quality standards.
• Affix Release and Rejection labels provided by QC for product batches at various stages of manufacturing.
• Highlight and escalate quality-related problems, ensuring thorough investigation and resolution.
• Lead root cause analysis and implement corrective and preventive actions (CAPA).
• Ensure compliance with documentation systems, ensuring accurate record-keeping and alignment with cGMP requirements throughout production activities.
• Manage non-conforming products by initiating actions, including rejection for investigation, rejection for destruction, or addressing out-of-specification issues.
• Conduct cGMP checks in the production department to ensure adherence to Good Manufacturing Practices and lead internal audits for continuous compliance.
• Develop and deliver training programs on related QA SOPs and cGMP practices for staff.
• Identify specific training needs and arrange technical training courses to enhance professional skills and regulatory knowledge.
• Collaborate with other departments (Production, QC, and Regulatory Affairs) to ensure alignment and compliance with quality standards and procedures.
• Contribute to process improvements by identifying inefficiencies or areas of risk and recommending corrective actions.

• Bachelor’s Degree in Pharmacy, Science, Medicine, Chemistry, or a related field.
• Minimum of (3-6) years of experience in a Quality Assurance role within the pharmaceutical industry.
• Experience in conducting cGMP audits
  , training staff, and ensuring compliance in production environments.
• Experience with regulatory audits (e.g., FDA, EMA) and maintaining audit readiness.
• Strong knowledge of cGMP (Current Good Manufacturing Practices) and pharmaceutical manufacturing standards.
• Strong attention to detail and ability to work accurately under pressure.
• Ability to work effectively in a team and across departments to achieve organizational quality goals.
• Strong problem-solving and decision-making skills.
• Ability to handle confidential and sensitive information with integrity.