Quality Assurance

Micro Labs; Bommasandra; On-site; INR 500,000 - 700,000; Full time

Job summary

Micro Labs in India is seeking a QA/QC professional to support batch release, documentation, and regulatory-compliance activities across manufacturing and packaging.

You will administer SOPs, CAPA, change controls, and validations, coordinate audits, and ensure data integrity while collaborating with regulatory affairs and cross-functional teams.

Join a fast-paced environment focused on quality, compliance, and continuous improvement within our manufacturing network.

Qualifications

• Experience in pharma QA/QC environments is essential.
• Familiarity with GMP, GLP and regulatory requirements.
• Strong documentation and audit preparation skills.

Responsibilities

• Prepare Batch Manufacturing Records and Master Formulas.
• Manage SAP process orders, stock checks, and MRP updates.
• Review and issue artworks, shade cards, and item codes.
• Prepare SOPs, QAPs, APQRs, and site validation documents.
• Support regulatory affairs and batch release reviews.
• Conduct internal and external audits and self-inspections.
• Handle deviations, CAPA, change controls, and risk assessments.
• Ensure data integrity and adherence to quality policies.
• Oversee cleaning validation and market complaint handling.

Skills

Quality Assurance

Documentation

GMP

SAP

Tools

SAP

Job description

Roles & Responsible :

• Preparation of Batch Manufacturing Record, Batch Packing Record and Master Formula Record and Master Packing records.
• SAP related Activities.(Process order Creation, Stock verification, MRP Updation)Issuance of Batch Manufacturing Record and Batch Packing Record.
• Checking, issuances and retrieval of Artworks and shade cards.
• Creation and Review of Item codes and Maintenance of Item Code List.
• Review and approval of export order copy and product pack specifications in SAP.Creation of Bill of Materials.
• Preparation and Review of SOP & QAP.
• Preparation & review of APQR, Graphical and statistical evaluation by Minitab-18 software.
• Implement the quality management system procedure such as Change control, Deviation & CAPA etc.
• Adherence to all the policies of the company and currentGood Manufacturing PracticesIssuance, retrieval and maintenance of documents and log sheets of the QC department
• Review of method validation, Process validation, stability study protocols and reports
• Review of Computer system validation Report.
• Preparation of Validation Master Plan, Site Master File and Quality Manual.
• Handling of cleaning validation activities.
• Preparation and evaluation of QRM.
• Handling of market complaints.
• To provide the support to regulatory affairs activities.
• Review of Completed batch records and Responsible for Batch Release.
• To perform internal and external audit management and audit compliance.
• To perform Self Inspection.
• Preparation and evaluation of risk assessment report.
• Review and approval of master documents like MFR,MPR etc.
• nvestigation , review and closure of OOS ,OOT and Lab Deviations.
• To adhere Quality Policy, Ornamental Policy ,EHS Policy and Data Integrity Policy.
• To complete the routine training in LMS.