Job Description
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.
