Manufacturing Quality Analyst

SBU / Location Vasai
Title / Grade: IPQC (In-Process Quality Control) Trainee
Department: QA
Reports To: HOD

• Qualification: B.Sc. / B.Pharm / Diploma / Degree in Mechanical, Production, Plastic, Chemistry or related field

• Shift: 8 Hours – Rotational Shift

• Industry Preference: Pharmaceutical Packaging / Medical Devices / Rubber / Plastic / Healthcare Manufacturing

Major Duties & Responsibilities:
· Conduct in-process inspection at defined stages of production. · Perform visual and dimensional inspection as per approved specifications. · Inspect products from processes including Molding, Assembly, Wadding, Printing, Sorting and Packing. · Conduct line clearance before commencement of production. · Verify product, batch, material and identification details. · Ensure correct product and material are being processed as per approved requirements. · Perform sampling as per approved sampling plans and procedures. · Identify, segregate and report defective / non-conforming products. · Monitor process rejection, rework and recurring defects. · Communicate quality deviations immediately to Production and QA. · Maintain IPQC inspection records, check sheets and other quality documents. · Ensure inspection records are completed accurately and in real time. · Verify measuring instruments used for inspection are calibrated and within validity. · Monitor critical process and product quality parameters. · Support investigation of quality deviations and root-cause analysis. · Support CAPA and corrective action activities. · Verify implementation of corrective actions where assigned. · Maintain product identification, traceability and batch / lot records. · Support product and process trials as required. · Support internal, customer and third-party audits. · Maintain proper housekeeping and 5S in the inspection / production areas. · Follow applicable SOPs, Work Instructions, Quality Manual and company policies. · Ensure compliance with applicable ISO 13485:2016, ISO 15378:2017

(GMP), EU MDR, CDSCO and relevant pharmacopoeial / customer requirements, as applicable to the product. · Report any out-of-specification or abnormal condition to the QA Manager / Quality Head. · Perform any other quality-related duties assigned by the QA Manager / Quality Head.

Required Skill Set: · Basic knowledge of Quality Control and IPQC. · Good observation and attention to detail. · Basic knowledge of visual and dimensional inspection. · Basic knowledge of measuring instruments. · Understanding of sampling and inspection procedures. · Ability to identify manufacturing defects. · Basic knowledge of documentation and traceability. · Basic MS Excel knowledge. · Basic understanding of GMP / Quality Management Systems. · Knowledge of ISO 13485 / ISO 15378 will be an advantage. · Willingness to learn manufacturing processes and quality systems.

Communication: · Good verbal and written communication skills. · Ability to communicate quality issues clearly and promptly. · Effective coordination with Production, QA, PPC, Stores and Maintenance. · Good reporting and documentation skills. · Ability to escalate critical quality issues to the QA Manager / Quality Head. · Willingness to work in shifts, if required.

Functional Competencies · In-Process Quality Control · Visual Inspection · Dimensional Inspection · Sampling & Inspection · Defect Identification · Line Clearance · Process Monitoring · Rejection & Rework Control · Product Traceability · Batch / Lot Documentation · Measuring Instruments · Calibration Awareness · Basic Root Cause Analysis · CAPA Awareness · GMP · ISO 13485:2016 · ISO 15378:2017 · EU MDR / CDSCO Awareness · Applicable Pharmacopoeial Requirements · 5S & Quality Systems

Behavioural Competence: · Attention to Detail · Quality Consciousness · Integrity · Accountability · Discipline · Learning Orientation · Analytical Thinking · Problem Solving · Teamwork · Communication Skills · Proactive Approach · Time Management · Adaptability · Willingness to Learn · Customer Focus · Ability to Work Under Pressure

• It is a Full Time Manufacturing job for candidates with Freshers.