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 workplace 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

Kindly share your updated resume on [email protected]

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