16/08/2025) Quality Assurance

Position Overview We are seeking an experienced Quality Assurance professional with 4 to 8 years of relevant industry experience to join our pharmaceutical company in a pivotal role focusing on Validation Qualification In-Process Quality Assurance IPQA Quality Management System QMS Review and Documentation for injectable products This position is critical for ensuring compliance with regulatory standards and maintaining high-quality standards throughout our manufacturing processes Key Responsibilities Validation and Qualification Lead and execute validation and qualification activities for equipment processes and systems specific to injectable manufacturing Develop and review validation protocols reports and risk assessments ensuring compliance with regulatory requirements Maintain comprehensive validation documentation and ensure adherence to established timelines In-Process Quality Assurance IPQA Implement robust IPQA strategies to monitor and assure the quality of injectable products during all manufacturing stages Conduct regular inspections audits and sampling of in-process materials to identify and address deviations promptly Collaborate closely with manufacturing teams to uphold adherence to SOPs GMP guidelines and quality standards Quality Management System QMS Reviewer Evaluate the effectiveness of the QMS for injectable manufacturing including SOPs policies and documentation Conduct internal audits to assess compliance with regulatory standards e g cGMP ISO and company procedures Lead and support initiatives for continuous improvement including CAPA implementation and quality metrics analysis Documentation Manage and maintain accurate documentation related to validation IPQA and QMS activities for injectable products Ensure documentation complies with regulatory guidelines and is readily accessible for audits inspections and regulatory submissions Develop review and update SOPs work instructions batch records and other quality-related documentation as needed Collaboration and Training Collaborate effectively with cross-functional teams including R D Manufacturing and Regulatory Affairs to drive quality initiatives and resolve quality-related issues Provide mentorship training and guidance to junior QA team members and manufacturing personnel on quality assurance principles practices and procedures Qualifications Skills Bachelor s degree in Pharmacy Chemistry Pharmaceutical Sciences or a related field 4 to 8 years of progressive experience in Quality Assurance within the pharmaceutical industry with a focus on injectable products In-depth knowledge of regulatory requirements and guidelines applicable to injectable manufacturing e g FDA 21 CFR Part 210 211 EU GMP Annex 1 Proven experience in leading validation activities IQ OQ PQ and proficiency in statistical analysis tools Strong analytical skills with a detail-oriented mindset and the ability to effectively manage multiple projects and priorities Excellent communication and interpersonal skills with the ability to collaborate effectively in a team environment Job Types Full-time Permanent Education Bachelor s Preferred Experience QA 1 year Preferred Work Location In person