Job Description:

Position : QA Manager

Company Location : Chhindwara District (Madhya Pradesh)

Experience : 10-15 Years

Eduction : Diploma/ BE/Btech/BSC/in Mechanical, Production,Plastic and Rubber.

Quality Management System:

- Approval of standard operating procedures.

- Verification of SOP wrt regulatory and standard documents

- Approval of standard Test procedures.

- Validation of STP (Standard Test Procedure) wrt Pharma COPEA, IEC document (Electro Technical Commission), IS Document (Indian Standard / BIS Standard).

- Oversee of manufacturing equipment, testing equipment, and process validation.

- Oversee compliance of QMS System wrt ISO 13485, EUMDR 745, ISO 15378, IMDR 2017, 21CFR Part 820, ISO 14971, USDMF, Australian Regulatory, North American Regulation

- Develop and implement of quality strategies and plan to meet company objective.

- Ensure QMS meets the regulatory compliance

- Post market surveillance and post market clinical follow up of product

- Handling of internal, external and customers audits

- Risk Management (product safety) of operations and process (PFMEA)

- Approval of manufacturing process flow

- Management Review Meeting of Internal Audits, External Audits, and Customer Audits.

- Monthly MRM of Business outcome, Resolving NC in TAT Ontime submission of regulatory documents Risk Management

Quality Control:

- Monitoring of batch production activity i.e. in-process quality control, raw material quality control and post production quality control (PDI), first piece approval check wrt approved TDS (Technical Data Sheet), drawing, mold, raw / pm material, product code, in-process quality monitoring wrt visual and AQL (Acceptance Quality Level), pre-dispatch inspection wrt AQL as well as customer specific AQL and cert of analysis (COA).

- Monitoring of analytical testing of semi finish, and finished product (FG), i.e. ESCR (Environmental Stress Crack Report) Test, Leak Test, MFI Test, Visual Inspection, ash content and specific gravity test, push pulled test, PH & TDS Test,

- Approval and release of batch and COA

- Area qualification and validation (area validation of injection molding, assembly, rubber molding, glass molding, flip-off seal process/assembly, packing and dispatch, quality control room/lab, warehouses

- Environment monitoring (temperature and humidity) of principal area

- Oversee handling, investigation, and closure of market complaints, ensuring root cause analysis and CAPA implementation.

- Oversee of analytical documents ie APQR, Customer Complaints Trend Analysis, Internal Deviation Trend Analysis, Internal NC Trend Analysis, Product Development Trend Analysis. Reduction of customer complaints, Reduction of rejection CAPA TAT

Validation & Qualification:

- Validation of manufacturing and testing equipment and process validation, IQ (Installation Qualification), PQ (Performance Qualification), OQ (Operational Qualification), DQ (Design Qualification),

- Trial runs and validation of mold ensuring capability, consistency, and compliance with product specifications.

- Trial and validation of RM and PM Material

- AHU validation, Validation TAT

New Product Development :

- Product realization wrt customer requirement

- Preparation of technical data sheet - MOC (Material of Construction), design qualification, graduation requirement, print plate, proposed drawing, BOM (Bill of Material),

- Approval of TDS from customers

- Prepare and update product technical file.

- Verification of TDS (RM and PM Verification, drawing verification, mold verification, print verification)

- Molding or trial of developed products

- Verification of molded products - mold trial report, material inspection report wrt TDS, drawing verification wrt molded products, print verification

- Validation of newly developed products - validation of FG, wrt product intended use, product description, regulatory compliance (USP requirement 661, 661.2, Indian European and US pharma COPEA), impurity (TSE, BSE). Compliance of raw material wrt primary drug

- Risk management of product (DFMEA)

- Approval of design history file and device history file and device file.

- Transfer of file to Planning and Production department / PPC

- Material code of the product, raw material, semi-finished material, finished product, implementation of product code system in ERP based software.

- Review and approve Annual Product Quality Reviews (APQRs) Nos. of NPD

- Customers Trials success rate Design History File and Device Master file

- Preparation of product code TAT.

- GMP & GDP, GLP (Good Laboratory Practices)

- Plan, conduct, and evaluate training on Good Documentation Practices (GDP) in line with ALCOA+ principles to ensure data integrity and traceability.

- Ensure comprehensive GMP training covering gowning and de-gowning procedures, hygiene practices, and bio-burden control, including validation and monitoring of gowning systems.

- Define, implement, and monitor cleaning and sanitation requirements for manufacturing and controlled areas to maintain compliance with GMP and contamination control standards.

- Oversee half-yearly water quality analysis, review test reports, assess trends, and ensure compliance with applicable pharmacopeia and regulatory requirements.

- Conduct and maintain GLP training programs aligned with IEC standards and ISO/IEC 17025, ensuring laboratory competence, accuracy of test results, and regulatory compliance.

- Promote and sustain a strong quality culture by driving quality awareness, accountability, and continuous improvement initiatives across all functions and levels of the organization.

Develop, update, and maintain the maintenance skill matrix as per defined guidelines and competency requirements. Training Hours as per calendar cGMP & GDP, GLP - Compliance

5S & Kaizen Implementation / Lean Management:

- Implement and sustain 5S practices within QA areas, laboratories, document control rooms, and quality workspaces to ensure compliance and efficiency.

- Ensure proper organization, labeling, and identification of QA documents, samples, reference standards, and inspection tools in line with GMP requirements.

- Conduct regular 5S audits, address non-conformities through corrective actions, and drive continuous improvement in quality systems and discipline. 5S Score Kaizen

- Lead and support Kaizen initiatives focused on improving product quality, process robustness, compliance, and reduction of deviations, rework, and complaints.

- Drive a culture of continuous improvement by analyzing quality data (deviations, CAPA, audits, trends) and standardizing best practices across QA processes. Kaizen Implementation

Health Safety and Environment

- Report unsafe conditions promptly to the Safety Officer.

- Avoid unsafe acts or shortcuts that risk operations or life.

- Actively engage in safety workshops, trainings, mock drills, and audits to strengthen the safety culture.

- Follow the Safety Policy, Zero Safety Incidents

Functional Competencies:

- Knowledge of regulatory Compliance & Standard

- Knowledge of QMS - ISO 13485, EUMDR 745, ISO 15378, IMDR 2017, 21CFR Part 820, ISO 14971, IEC 17025, USDMF, Australian Regulatory, North American Regulation

- Knowledge of Risk Assessment (DFMEA, PFMEA)

- Knowledge of 7QC Tools

- Knowledge of Design & Development of Product

- Knowledge of validation, verification and qualification

Behavioral Competencies:

- Leadership Skills

- Strategic Thinking

- Problems Solving & Decision Making

- Planning & Prioritization

- Analytical Skills

- Drive for Results

- Customer Focus

- Team Development

- Innovation

Please reply with your updated Resume OR whatsapp 9834616970

Laxmikant Parate
Assistant Manager-TA