Pharma QA & Compliance Lead

MEDICAMEN BIOTECH LIMITED; New York (NY); On-site; USD 70,000 - 100,000; Full time

Job summary

MEDICAMEN BIOTECH LIMITED is seeking a QA Officer/Executive in the Department of Quality Assurance to supervise IPQA activities and ensure GMP compliance in manufacturing and packing processes.

The role involves preparing regulatory documentation, issuing protocols, and distributing SOPs across departments. Candidates should have M.Pharm or B.Pharm with pharma formulation experience and be capable of planning internal audits and training programs.

Qualifications

• Candidate should have M.Pharm or B.Pharm with pharma formulation background.
• Knowledge of GMP/regulatory guidelines and documentation practices.
• Strong QA mindset with attention to detail and compliance.

Responsibilities

• To check finished products during manufacturing and packing (IPQA).
• Issuing of Change Control and maintain the log.
• Preparing BMR, SOPs, RMS, FPS and issuing protocol.
• Distribution of SOPs, guideline, formats to respective department.
• Implementation of good manufacturing practice.
• To monitor Calibrations and validations process as per schedule.
• To plan and execute training programs.
• To plan and execute internal audit.
• To assist QC for maintaining records of analysis as per specifications.
• Preparation of APQR.

Skills

Quality Assurance

GMP knowledge

Training & development

Education

M.Pharm

B.Pharm

Job description

MEDICAMEN BIOTECH LIMITED is seeking a QA Officer/Executive in the Department of Quality Assurance to supervise IPQA activities and ensure GMP compliance in manufacturing and packing processes.

The role involves preparing regulatory documentation, issuing protocols, and distributing SOPs across departments. Candidates should have M.Pharm or B.Pharm with pharma formulation experience and be capable of planning internal audits and training programs.