Executive -Manager For QA (Quality Assurance ) IN API Pharma Ahmedabad

Success Vibrant Hr & Pr Solutions; Dholka, Bavla; In loco; INR 900.000 - 1.800.000; Tempo pieno

Descrizione del lavoro

API Pharma Co. in Ahmedabad seeks a QA Executive/Manager to oversee QA activities for an API production plant, ensuring cGMP compliance and robust quality systems across chemical synthesis and bulk drug manufacturing.

The role emphasizes CAPA investigations, deviation handling, data integrity, and regulatory readiness, with responsibilities spanning documentation reviews, audits, and tech transfer from R&D to production.

Competenze

• B.Pharm/M.Pharm/M.Sc. in Organic Chemistry or Pharmaceutical Chemistry.
• 2–9+ years hands-on API/bulk drug QA experience.
• Strong knowledge of cGMP and regulatory compliance.
• Experience with CAPA, deviation handling and root-cause analysis.
• Familiarity with API process validation and equipment qualification (DQ/IQ/OQ/PQ).
• Good technical writing and communication skills.

Mansioni

• Maintain and monitor QMS elements including SOPs, change controls, deviations, and incident reports.
• Initiate, track, and close CAPA investigations alongside OOS/OOT investigations.
• Review and approve Master Batch Records (MBR), batch production records, validation protocols, and analytical test data.
• Oversee lab notes, R&D scale-up studies, process validation, and technology transfer from R&D to pilot and commercial production.
• Ensure adherence to cGMP, WHO, ICH, and USFDA guidelines; conduct internal audits and face regulatory inspections.
• Monitor data integrity and line clearance on shop-floor, ensuring complete electronic and paper records.

Conoscenze

cGMP knowledge

Regulatory compliance

CAPA investigations

Root-cause analysis

Process validation

Equipment qualification

Technical writing

Communication skills

Formazione

B.Pharm

M.Pharm

M.Sc. Organic Chemistry/Pharmaceutical Chemistry

Descrizione del lavoro

QA- QUALITY ASSURANCE EXECUTIVE /MANAGER FOR API PHARMA CO AT AHMEDABAD

A Quality Assurance (QA) Executive /Managaer in an Active Pharmaceutical Ingredient (API) plant in Ahmedabad manages compliance, documentation, and quality systems across chemical synthesis and bulk drug manufacturing units.

Key Responsibilities

Quality Management System (QMS):

Maintain and monitor QMS elements, including Standard Operating Procedures (SOPs), change controls, deviations, and incident reports.

• CAPA & Investigations: Initiate, track, and close Corrective and Preventive Actions (CAPA) alongside Out of Specification (OOS) or Out of Trend (OOT) investigations.

Documentation & Review:

Review and approve Master Batch Records (MBR), batch production records, validation protocols, and analytical test data.

Development Quality Assurance (DQA):

Oversee lab notes, R&D scale-up studies, process validation, and technology transfer from R&D to pilot and commercial production.

• Audits & Compliance: Ensure adherence to cGMP (Current Good Manufacturing Practice), WHO, ICH, and USFDA guidelines; conduct internal audits and face regulatory/client inspections.
• Data Integrity & Line Clearance: Monitor shop-floor activities, line clearances, and ensure complete electronic and paper-based data integrity.

Eligibility & Requirements

• Education: B.Pharm, M.Pharm, M.Sc. in Organic Chemistry, or Pharmaceutical Chemistry.
• Experience: Typically 2 to 9+ years of hands-on experience in API or bulk drug manufacturing QA/IPQA.
• Key Skills:
• Strong knowledge of cGMP and regulatory compliance.
• Experience with root-cause analysis (CAPA, deviation handling).
• Familiarity with API process validation and equipment qualification (DQ/IQ/OQ/PQ).
• Good technical writing and communication skills.