Quality Assurance Lead

Archean Chemical Industries Limited; Jhagadia; Sur place; INR 1 500 000 - 2 600 000; Plein temps

Résumé du poste

Archean Chemical Industries Limited in Jhagadia is seeking a Senior QA Lead to establish and run the quality management system for bromine derivatives. You will drive ISO 9001/IMS compliance, lead customer audits, and ensure regulatory conformity, with responsibility for QA/QC operations and documentation.

The candidate should have 8–12 years in QA, a strong background in chemical/pharma quality systems, and a track record of CAPA and deviations.

Qualifications

• Educational background as listed in the qualifications.
• Experience of 8–12 years in QA/QC, preferably in chemical/pharma.
• Hands-on QA/QC operations, regulatory inspections and supplier audits.

Responsabilités

• Set up and maintain ISO 9001 and IMS across the plant.
• Define specifications and test methods for materials and products.
• Develop and validate analytical methods for purity testing.
• Oversee testing, batch release, and issue CoAs.
• Qualify and audit raw-material suppliers.
• Investigate deviations and manage CAPA.
• Review quality documentation during scale-up and tech transfer.
• Lead customer audits and respond to quality questionnaires.
• Maintain batch records and data integrity.
• Manage QC chemists and instrument calibration.

Connaissances

QA/QC procedures

ISO IMS

Audit coordination

CAPA & deviation

Analytical instruments

ERP & MS Office

Formation

B.Tech in Chemical Engineering

M.Sc. in Chemistry

B.Pharm.

Description du poste

Greetings from Archean Chemical Industries Ltd!!

We are looking for a QA Lead for our company at Jhagadia location.

Please find below the details regarding the job.

Job Details

Department : QA-QC

Designation - Quality Assurance Lead

Job Level - Senior

Experience Required - 8 to 12 Years

Location -Jhagadia

Reporting To - DGM-Operations

Employment Type - Full-Time

2. Job Purpose

To establish and run the quality management system for the bromine derivatives business, ensuring product quality, regulatory compliance and adherence to IMS and ISO standards, and to carry the company through customer qualification and audit to approved supplier status.

3. Key Job Responsibilities

• Quality management system: Set up and maintain ISO 9001 and the integrated management system (IMS) across the plant.
• Specifications and SOPs: Define specifications and test methods for raw materials, in-process stages and finished products.
• Analytical methods: Develop and validate test methods for purity and impurity testing in collaboration with R&D.
• Testing and batch release: Oversee testing of raw materials, in-process samples and finished goods, approve batch release and issue certificates of analysis (CoAs).
• Supplier quality: Qualify and audit raw-material suppliers, including suppliers of key starting materials.
• Deviation and CAPA management: Investigate out-of-specification results, deviations and customer complaints, and drive root-cause analysis and corrective and preventive actions (CAPA).
• New product quality: Review quality documentation and validation batches during scale-up and technology transfer of new molecules.
• Customer audits: Lead customer audits, respond to quality questionnaires and maintain customer-specific quality agreements.
• Documentation and data integrity: Keep batch records, lab data, stability studies and retained samples traceable and audit-ready.
• Team and lab management: Manage QC chemists, instrument calibration and quality training across the plant.

4. Educational Qualification & Experience

• Educational Qualification: B.Tech in Chemical Engineering, M.Sc. in Chemistry, or B.Pharm. Certification in Quality or IMS is an advantage.
• Relevant Experience: 812 years in the QA domain, preferably in API, bulk drugs, API intermediates or specialty chemicals supplying pharmaceutical customers.
• Hands-on experience in QA/QC operations in chemical or process industries.
• Experience in handling customer audits and regulatory inspections.
• Experience in IMS/ISO implementation and audit coordination preferred.

5. Required Skills & Competencies

A. Technical & Functional Skills

• Strong knowledge of QA/QC procedures, chemical testing, laboratory operations and quality standards.
• Familiarity with IMS/ISO systems, audits, non-conformance management and documentation.
• Knowledge of deviation, CAPA, change control and in-process quality assurance.
• Proficiency in analytical instruments and laboratory software.
• Proficiency in ERP systems and MS Office.

B. Quality Systems & Audit Skills

• Quality Management System implementation and continuous improvement.
• Internal and external audit management, including customer and regulatory audits.