Coordinator - Quality, Vantage

Job Description Position Title : Coordinator Quality, Vantage Organization Context Position Title Coordinator Quality, Vantage Employee Name ABC Grade M09 Department Quality Location: Shirwal Reports To Shishir Bakshi Reported By NIL ACG is the world's only integrated pharma manufacturing solutions company. We are headquartered in Mumbai , India. ACG has a presence in over 100 countries with its products and services that strive to provide world-class technology across multiple domains. We offer a complete range of solutions beginning with empty capsules; granulation and tablet coating; capsule filling; tabletting; packaging films; blister packing and carton packing to the end-of-line solutions and track and trace systems. We have an opportunity in ACG Capsule / ACG Engineering / ACG Pharma Packaging / ACG Inspection of a position title. - Job Objective The Junior Executive The primary objective of this role is to ensure that products consistently meet customer expectations and comply with all applicable regulatory, quality, and certification requirements. QA & IPQC is responsible for supporting the implementation and maintenance of quality standards throughout the manufacturing process at Vantage Nutrition. This includes performing in-process quality checks, sampling at various stages, and documentation. It also involves quality assurance activities, such as monitoring critical process parameters, ensuring adherence to Good Manufacturing Practices (GMP), and verifying compliance with product specifications and regulatory standards. The person shall assist in identifying and reporting deviations, complaints, supporting root cause analysis, and contributing to corrective and preventive actions. The role also involves ensuring compliance with new or updated quality requirements. - Primary responsibilities - In-Process Quality Assurance (IPQA) Activities - Perform in-process quality checks: Like; visual inspections and sampling at different stages of manufacturing (RM, PM, bulk, SFG, FG) as per defined sampling plans. - Monitor Critical Control Points (CCP), Operational PRPs (OPRP), PRPs as per GMP, FSSC and GFSI requirements. - Perform line clearance and verify equipment and area readiness before dispensing, production, packaging, and after cleaning operations. - Perform pre-dispatch inspections and ensure product compliance before release. - Preparation, Issuarnce and Review of Batch Manufacturing Records (BMR), Batch Packaging Records (BPR), and associated in-process records for completeness and compliance. - Assist in drafting and updating SOPs, in-process formats, checklists. - Identify, document, and escalate deviations or non-conformances; support root cause analysis and corrective/preventive actions. - Maintain IPQC laboratory support equipment calibration, verification, and routine analysis as per defined specifications and schedules. - Quality Control (QC) Support Activities - Perfomning vehicle inspections and sampling of received raw material/ packing materials. Identifying non conformities and communicating the same with relevant stckholders. - Assist in the implementation and execution of specifications and methods of analysis for raw materials, packaging materials, semi-finished goods, and finished products. - Ensure availability and proper use of SOPs, logbooks, formats, and checklists within the QC function. - Coordinating with external service provider for equipment calinrations and area monitoring. - Participate in ensuring Good Laboratory Practices (GLP) by checking equipment calibration status, maintaining hygiene, and preparing for internal audits. - Quality Assurance Activities - Assist in reviewing and verifying QA documents related to products and processes, such as specifications, stability reports, labelling, and safety data. - Support regulatory compliance activities including GMP, FSMS, HACCP, FSSC 22000 and GFSI or Global standard requirements. - Performing GMP audit and Internal audis as per FSSC and report preparations. - Participate in QA reviews during product development for regulatory alignment and documentation accuracy. - Maintain and update QA and IPQC records, logs, and registers in line with audit and regulatory requirements. - Support document control activities, including preparation, review, issuance, and archival of quality documents. - Assist in data collection and documentation for product complaint investigations from dispensing to dispatch. - Support the preparation of investigation reports and implementation of corrective/preventive actions to minimize reoccurrence. - Participate in internal and external audit preparations by ensuring readiness of documents, logbooks, and compliance data. - Key Result Areas - Ensure quality checks for RM, PM, SFG & FG as per specifications. - Perform line clearance and routine IPQA checks during manufacturing and packaging. - Maintain IPQC lab cleanliness, equipment readiness and calibrations, and performing sampling activities. - Coordinate and maintain records for internal and external instrument calibrations. - Support GMP at shop floor and ensure GLP practices in lab operations. - Complete and maintain QA/IPQA documents, logs, and records as per SOPs. - Assist in audit preparations and implement post-audit actions. - Assist in Complaint investigation, RCA, CAPA readiness and effectiveness monitoring. - Performing GMP and Internal audis and report preparations. - Key Interfaces Internal Interfaces External Interfaces - Production - Stores - Maintenance - Purchase - Finance - Sales - Customers - External Service Providers - Suppliers - ACG Persona Persona Level Competency Level Innovator Communication Entrepreneur Innovation Integrator Problem Solving Partner Corporate Etiquette Drive for Consistent results - Educational and Experience Requirements Minimum Requirement Desired Level of Education B.Sc./ B.Pharma - M.Sc Experience Minimum 5 - 7years - 7 Years