Position Vacant QA Analyst

Job Purpose

To support the day to day running of QA to a site.

Key Job Responsibilities 1. Responsible for the Issuance and review of batch manufacturing records and other

production documents for compliance and completeness.

2. Manage document control activities including issuance, revision, archival, retrieval,

and obsolescence of SOPs, forms, specifications, and records.

3. Review and manage deviations, incidents, and non-conformances.

4. Ensure timely investigations, root cause analysis, CAPA implementation, CAPA

effectiveness and their closure in accordance with quality system requirements.

5. Review and manage change control records with timely closure.

6. Perform Quality Risk Assessments (QRA) and support implementation of risk

mitigation measures.

7. To ensure compliance of site with requirements of IMS, EFfCI & EXCiPACT GMP,

Halal, Kosher and other applicable standards.

8. Coordinate and conduct internal audits. Provide support and participate in customer

audits, supplier audits, external audits and regulatory inspections.

9. Facilitate Management Review Meetings and monitor timely completion of actions

arising from management review decisions.

10. Monitor compliance with Good Documentation Practices (GDP), Data Integrity

(ALCOA+), and Quality System requirements across the site.

11. Manage training records, training compliance, and effectiveness evaluation activities.

12.



Support qualification, validation, and verification activities as applicable.

13. Participate in investigation of customer complaints and implementation of corrective

actions.

14. Ensure continual improvement of Quality Management System processes and

compliance standards.

15. To deputize for their line Manager in their absence for matters relating to QA.

16. To implement and maintain appropriate training regimes for new and existing QA staff

to meet departmental objectives.

Desired profile of the

candidate

MSc. Degree with at least 4 -10 years of experience in QA Process/Operations, in Pharma

or Chemical companies. QMS Lead Auditor

Knowledge/Skills/ Abilities

Required

- SAP / IT user.
- Attention to detail, teambuilder, good interpersonal skills.
- Good knowledge of site processes.
- Robust knowledge of GMP, GDP, ALCOA+ and Data Integrity principles.
- Experience in deviation, CAPA, change control, and quality risk management systems.
- Proficiency in document control, batch record review, and quality documentation.
- Root cause analysis and problem-solving skills.

- Internal audit, customer audit, and regulatory inspection support skills.
- Effective verbal and written communication with cross-functional teams.

Location of posting Dahej, Gujarat.

Reports to Quality Manager

Share CV's : (phone hidden) | Rohan Chavda

📌 Qa Analyst (Dahej)
🏢 CIEL HR
📍 Dahej