Steribio

At Steribio Lifesciences, we dont just manufacture IV fluids we deliver lifelines. Born from a vision to transform patient care, our story is rooted in passion, precision, and purpose. At Steribio Lifesciences, we dont just manufacture IV fluids we deliver lifelines. Born from a vision to transform patient care, our story is rooted in passion, precision, and purpose. Because at Steribio, every drop saves a life and every life deserves the best. Position: QA Manager Location: Patas Experience: 8 to 10 years Industry: Pharmaceutical (LVP formulations Injectables) Roles & Responsibilities Quality Policies and Procedures: Establish and enforce quality assurance policies, procedures, and guidelines specific to LVP, injectable formulations, and IV fluids , ensuring consistent and compliant product quality throughout all manufacturing stages. Quality Standards: Define and communicate quality standards and product specifications for LVPs, sterile injectables, and IV fluid formulations , ensuring they meet or exceed regulatory and customer expectations. Regulatory Compliance: Ensure strict compliance with GMP, GLP, WHO, and other industry-specific regulations related to the manufacturing of sterile LVPs, injectables, and IV fluids , including validation, environmental monitoring, and sterility assurance requirements. Quality Audits: Conduct internal quality audits and inspections of sterile manufacturing areas, cleanrooms, and filling lines to assess adherence to quality standards and identify opportunities for improvement. Quality Control: Implement robust quality control procedures for raw materials, in-process samples, and finished LVP/IV fluids , including sterility testing, particulate matter testing, pH, osmolarity, and endotoxin limits. Process Improvement: Identify areas for process optimization in sterile filtration, autoclaving, terminal sterilization, filling, and packaging to reduce defects and enhance process efficiency. Root Cause Analysis: Investigate deviations, out-of-specification (OOS) results, and customer complaints related to sterile injectable and IV fluid products , performing root cause analysis and implementing preventive actions. Documentation: Maintain accurate documentation for all batch manufacturing records (BMR), batch packaging records (BPR), sterility test reports, media fill reports, validation documents, and audit findings in compliance with GMP. Training and Education: Develop and deliver training programs for production and QC teams on aseptic practices, cleanroom behaviour, contamination control, quality procedures, and best practices in LVP and injectable manufacturing. Preferred candidate profile Key Skills & Competencies: Strong knowledge of cGMP, WHO, , and other regulatory standards. Hands-on experience in Injectables manufacturing. Expertise in equipment qualification, FAT/SAT, validation, and vendor audits. Strong analytical skills to assess quality risks and implement proactive solutions. Excellent documentation, communication, and leadership abilities. Ability to work in a start-up manufacturing environment and build systems from the ground up. Qualifications & Experience: B.Pharm / M.Pharm / M.Sc. in Pharmaceutical Sciences or related field. 10+ years of experience in Quality Assurance (QA) in a pharmaceutical manufacturing setup. Must have experience in handling LVP Injectable dosage forms. Experience in setting up QA systems for new manufacturing facilities will be highly preferred.