QA Officer / Executive – Pharma API & Formulations

Key Responsibilities

• Provide details about our Pharma QMS solutions to prospective clients
• Implement and maintain Quality Assurance systems and procedures.
• Study & Prepare, review Project scope documentation, SOPs, protocols, and reports for customers
• Conduct and participate in internal, customer, vendor, and regulatory audits.
• Study and assess manufacturing and quality processes to ensure GMP compliance at customer site.
• Participate in customer meeting & presentations.

Required Education Qualifications

UG:

• B.Pharma
• B.Sc (Chemistry)
• Diploma in Chemical Engineering
• B.E./B.Tech (Chemical Engineering)

PG (Preferred):

• M.Pharma
• M.Sc (Chemistry/Biochemistry)
• M.E./M.Tech in Chemical Engineering

Required Skills

• Quality Assurance (QA)
• GMP, GLP, and QMS Implementation
• SOP Preparation and Documentation
• Process Validation
• Regulatory Compliance
• Internal and External Audits
• CAPA, Deviations, and Change Control
• ISO Documentation
• Vendor and Customer Audits
• Strong English Communication Skills
• Strong Presentation skills
• Good Computer Proficiency

Preferred Experience

• Experience in API, Bulk Drug, or Formulation manufacturing companies.
• Exposure to US FDA, MHRA, EU GMP, and other regulatory inspections.
• Experience in handling customer queries and audit observations.

Candidate Profile

• Strong understanding of pharmaceutical quality systems and regulatory requirements.
• Detail-oriented with excellent documentation skills.
• Good analytical and problem-solving abilities.
• Ability to work effectively with cross-functional teams.
• Confident in interacting with customers and regulatory authorities.