We are seeking experienced QA Head with astrong background in Pharmaceutical Packaging industry as well ISO 13485:2016.Thisrole involves all quality assurance activities, ensuring product and process quality&driving continuou improvement initiatives. Gratuity Provident fund Annual bonus
Job Summary: We are seeking an experienced Quality Assurance Manager with a strong background in Pharmaceutical Packaging industry as well ISO 13485:2016/ 15378 also regulatory compliance for medical devices. This role involves overseeing all quality assurance activities, ensuring product and process quality, and driving continuous improvement initiatives. The ideal candidate will have robust leadership skills, excellent knowledge of QMS, and a proactive approach to maintaining compliance and product integrity. Key Responsibilities: Define and implement the quality assurance strategy aligned with organizational goals. Develop, implement, and maintain SOPs, work instructions, and controlled documents. Lead and mentor the QC team across documentation, validation, and compliance function Ensure compliance with all regulatory requirements and facilitate successful audits (regulatory, customer, and internal). Conduct internal audits and manage CAPA (Corrective and Preventive Action) processes. Validate Molds, processes, and equipment (IQ/OQ/PQ) before production initiation. Approve supplier qualifications and verify COAs for raw materials. Review and approve artwork, packaging specifications, and change controls Prepare and maintain traceability systems, line clearance procedures, and batch records. Define in-process quality checkpoints and lead IPQC training and planning. Investigate deviations and non-conformances with detailed root cause analysis. Lead training programs, update skill matrices, and ensure regulatory compliance. Oversee the documentation process, ensuring proper entries and audit-readiness. Support continuous improvement initiatives to enhance product and process quality. Collaborate with production for product lifecycle quality planning. Represent the company during regulatory inspections and customer audits. Build and sustain a strong quality culture throughout the organization
Key Responsibilities Co-ordination with Production, Assembly, Packing and Stores. To take trial of new molds and prepare process monitoring sheets and get them authorized In process inspection sheets, line clearance forms, BMR, BPR etc Provident fund Annual bonus Office cab/shuttle
Key Skill: Strong problem-solving skills with the ability to analyze and troubleshoot complex issues. Excellent attention to detail and ability to work independently with minimal supervision. Knowledge of preventive maintenance practices and ability to implement them effectively. Ability to interpret technical drawings, blueprints, and mold designs. Runner, Assembly/Disassembly/Hot Tip & Union change/ TC change/Wire connection Proficient in the use of maintenance tools, diagnostic equipment, and repair techniques for injection molds. In-depth understanding of mold design, mold flow, and material properties. Ability to analyze and optimize mold performance, ensuring efficiency and minimizing defects. Experience with process control and improving molding parameters for quality production. Ability to lead, mentor, and develop a team of maintenance engineers and technicians. Role & Responsibilities: Determined schedule planned (Preventive maintenance) according to production. Preventive maintenance (PM) for all types of Moulds. Hot Runner, Assembly/Disassembly/Hot Tip & Union change/ TC change/Wire connection. Trouble shooting for all online running moulds as well as offline moulds too. Suggestions for new/old/Obsolete mould development. Coordinate with suppliers for regarding mould accessories. Coordinate with outsource vendor for mould correction/repairs/matching. Taking new mould trials. Maintaining stocks for all required items which is related to mould. To do mould room improvement. To attend all breakdowns related to mould on running machine. To make mould ready before its validation Role & responsibilities Preferred candidate profile