Associate Manager (QA)

Laxmi Organic Industries Ltd.; Chiplun; On-site; INR 1,800,000 - 2,600,000; Full time

Job summary

Laxmi Organic Industries Ltd. in Maharashtra is seeking an Associate Manager - Quality Assurance for the Lote site. Lead end-to-end quality processes, audits, CAPA, and supplier qualification to ensure product quality and regulatory compliance.

You should hold an MSc with 8–10 years of GMP QA experience, strong analytical and leadership skills, and SAP proficiency. This permanent, on-site role offers an opportunity to drive continuous quality improvements and Right First Time culture.

Qualifications

• Essential: MSc in a relevant science field.
• Experience: 8–10 years in GMP documentation, regulatory docs, and customer audits.
• Proficiency in Quality tools like 7 QC tools, Quality risk assessment, SPC, FMEA, etc.

Responsibilities

• Ensure ISO 9001, ISO 14001, ISO 45001, QMS, SOPs, and regulatory compliance.
• Review/approve BMR, BPR, analytical reports, quality docs, and product release docs.
• Investigate deviations, OOS/OOT, non-conformances, customer complaints; perform RCA and CAPA.
• Manage QMS activities: document control, risk assessment, process improvements.
• Plan and support internal, customer, certification, vendor, and regulatory audits; close audit observations.
• Lead supplier qualification: supplier audits, COA, TDS, SDS, quality agreements, AVL management.
• Coordinate process validation, IQ/OQ/PQ, calibration, quality monitoring.
• Drive continuous quality improvement; run GMP/QMS training; promote RFT and Zero Defect culture.

Skills

Quality management

Vendor qualification

CAPA

Root cause analysis

Document control

Risk assessment

SAP usage

Interpersonal skills

Team player

Communication

Education

Master of Science - MSc

Tools

SAP

Job description

We are looking for candidates interested for AM - Quality for Chiplun location.

Job Title: Associate Manager - Quality Assurance

Department: Quality Assurance

Functional Area: QC & QA

Type of Job: Permanent

Location: Lote

Job Purpose

(why job exists / what it must achieve)

• To develop quality orientation and culture; To manage the end-to-end Quality processes, Audits, vendor qualification, Customer compliances and continuous quality improvement at Lote Site.

Role and Responsibilities

• Ensure compliance with ISO 9001, ISO 14001, ISO 45001, QMS, SOPs, and applicable regulatory requirements.
• Review and approve Batch Manufacturing Records (BMR), Batch Packing Records (BPR), analytical reports, quality documents, and product release documentation.
• Investigate deviations, OOS/OOT results, non-conformances, customer complaints, and quality incidents; perform Root Cause Analysis (RCA) and implement effective CAPA.
• Manage Quality Management System (QMS) activities, including, document control, risk assessment, and process improvements.
• Plan, conduct, and support internal audit, customer, certification, vendor, and regulatory audits, ensuring timely closure of audit observations.
• Lead vendor qualification activities, including supplier audits, review of quality documentation (COA, TDS, SDS, Quality Agreements), vendor performance evaluation, and Approved Vendor List (AVL) management.
• Coordinate process validation, equipment qualification (IQ/OQ/PQ), calibration, and quality monitoring to ensure consistent product quality and regulatory compliance.
• Drive continuous quality improvement by implementing quality initiatives, conducting GMP/QMS training, monitoring key quality metrics, supporting cross-functional teams, and promoting Right First Time (RFT) and Zero Defect culture.

Required Knowledge (of any equipment / Tools and techniques / Software/skills )

• Quality Management Systems (ISO 9001, ISO 14001, ISO 45001)
• Vendor Qualification and Supplier Audits,
• Deviation Management, CAPA, OOS/OOT Investigation
• Root Cause Analysis
• Document Control and Risk Assessment.
• Strong interpersonal skills with excellent oral and written communication skills,
• A strong team-player with a passion to improve the product quality,
• Organized and self-motivated,
• Strong listening and influencing skills to foster an open, innovative and responsive environment and to drive change,
• Promote and support an environment that encourages productivity, continuous improvements, teamwork, and a high level of professionalism,
• Proficiency in SAP usage

Education & Experience

Education

Essential: Master of Science - M.Sc

Experience

Essential: 08-10 yrs.

• Exposure to GMP documentation / Regulatory Documentation / Pharma Customer audits,
• Proficiency in Quality Tools like 7 QC Tools, Quality risk Assessment, SPC, FMEA etc.

People Management:

Internal

External

• Manufacturing
• Supply chain management
• HR & Administration
• Accounts and Finance
• Procurement
• Projects

• Customers