Quality Assurance Lead (Jhagadia)

Quality Assurance Lead (Jhagadia)

21 Oct
|
Archean Chemical Industries
|
Jhagadia

21 Oct

Archean Chemical Industries

Jhagadia

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

- Solid 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.
- Process validation execution and documentation.
- Batch record and GMP documentation review.

C. Behavioral Competencies

- Leadership and team management.
- Analytical and problem-solving skills.
- Attention to detail and discipline in documentation.
- Effective communication and reporting.
- Ownership and accountability for quality decisions.

6. Language Proficiency

- Mandatory Languages: English and Hindi.
- Required Proficiency: Good written and verbal communication skills in both languages.

7. Key Performance Indicators (KPIs) Performance will be evaluated against agreed business and functional objectives, including:

- Successful completion of customer audits and achievement of approved supplier status.
- Timely closure of deviations, CAPA and non-conformances.
- Compliance with ISO/IMS and GMP certification requirements.
- Reduction in customer complaints and quality rejections.
- Timeliness and accuracy of batch release decisions.
- Completeness and audit-readiness of quality documentation.

8. Job Interfaces

- Internal Stakeholders: R&D;, Process, Production, Procurement, Logistics, EHS and Management.
- External Stakeholders: Customers and customer audit teams, certification bodies, regulatory authorities, external laboratories and suppliers.

Interested candidates with relevant experience share cvs to [email protected]

Regards

Uma Paul

📌 Quality Assurance Lead (Jhagadia)
🏢 Archean Chemical Industries
📍 Jhagadia

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