Medreich Looking for Quality Assurance Professionals

Medreich Limited; Bengaluru; In loco; INR 1.200.000 - 1.800.000; Tempo pieno

Descrizione del lavoro

Medreich seeks a Quality Assurance professional at its Pilot Plant in Hoskote, Bengaluru. Ideal for candidates with 5–9 years in pharma QA and regulatory compliance, to ensure products meet cGMP standards and maintain quality systems.

The role focuses on reviewing formulation and production documentation, performing audits, and collaborating with R&D, regulatory teams, and external customers to sustain quality across manufacturing operations.

Competenze

• 5–9 years of experience in Quality Assurance within pharmaceutical manufacturing.
• In-depth knowledge of cGMP, SOPs, process validation.
• Experience with regulatory and customer audits.
• Proficiency with QLMS and SAP for releases.

Mansioni

• Review Formulation LNB, pre-formulation study reports, Master formula card, scale-up reports.
• Prepare/review Master Production documents (BMR, BPR).
• Support QMS activities: change control, deviation, CAPA, risk assessment, OOS/OOT and internal audits.
• Knowledge of equipment qualification.
• Knowledge of DMS, LMS and SAP usage.
• Adhere to regulatory guidelines (ICH, EU-GMP, Health Canada).

Conoscenze

Quality systems knowledge

Regulatory compliance

Audit readiness

Communication

cGMP knowledge

Formazione

Bachelor’s or Master’s degree in Pharmaceutical Sciences, Chemistry, or related field

Strumenti

QLMS

SAP

Descrizione del lavoro

Medreich, a global pharmaceutical company, is hiringQuality Assurance professionalsfor theirPilot PlantinHoskote, Bengaluru. Ideal for candidates with5 to 9 years of experience in pharmaceutical quality systems and regulatory compliance.

As aQuality Assurance professional at Medreich, your responsibilities include implementing and maintaining pharmaceutical quality systems in line with company policies and regulatory standards. Your role focuses on ensuring that all products manufactured at the pilot plant meet the necessary cGMP requirements.

Key Responsibilities

• Candidate should have experience in review of the Formulation LNB, Pre-formulation study report, Master formula card, scale-up report, product development report.
• Candidate must have adequate knowledge on process validation concept and on preparation / review of process validation protocols / reports, hold time study protocols / reports.
• Preparation / review of Master Production documents (BMR, BPR).
• Knowledge on QMS activities (Change control, Deviation, CAPA, CAPA effectiveness, risk assessment, OOS, OOT, Incidents and Internal Audit).
• Knowledge on Equipment qualification.
• Knowledge on DMS, LMS and SAP.
• Knowledge on regulatory guidelines (ICH, EU-GMP and Health Canada).

Qualifications and Skills

• Educational Requirement: Bachelor’s or Master’s degree in Pharmaceutical Sciences, Chemistry, or a related field.
• Experience: 5 to 9 years of experience in Quality Assurance within a pharmaceutical manufacturing environment.
• In-depth knowledge of cGMP, SOPs, process validation, and quality systems.
• Strong experience in handling regulatory and customer audits.
• Proficiency in using QLMS and SAP for material and process order releases.
• Excellent communication skills to collaborate with various departments, including R&D, regulatory teams, and external customers.

Location: Medreich’s Pilot Plant in Hoskote, Bengaluru.