Executive-QA/RA

GPC Medical Ltd.; Ghaziabad District; On-site; INR 400,000 - 650,000; Full time

Job summary

GPC Medical Ltd. is seeking a detail-oriented Quality Assurance & Regulatory Affairs professional to support the maintenance of the QMS, documentation, production records, quality processes, and regulatory compliance activities.

You will manage document controls, review BMRs, maintain quality logs, and assist in regulatory submissions. The role involves audits, inspections, and ensuring traceability of quality records with cross-functional collaboration.

Qualifications

• Experience with QMS documentation and record control is required.
• Familiarity with ISO 13485 and regulatory requirements is advantageous.
• Knowledge of CAPA, deviations, non-conformities, and complaint handling.
• Excellent documentation, accuracy, and coordination skills.
• Proficiency in MS Office, especially Excel and Word.

Responsibilities

• Prepare, review, update, and maintain QMS documents, procedures, formats, and records.
• Issue controlled documents and maintain document control registers and records.
• Review Batch Manufacturing Records (BMRs) and supporting production documentation for accuracy and completeness.
• Maintain quality logs and trackers: Customer Complaints, CAPA, NC, Deviations, and other quality records.
• Maintain reference samples, stability records, and associated documentation.
• Support customer complaint investigations and internal quality investigations.
• Prepare, review, and update regulatory and technical documentation.
• Assist in regulatory submissions and ensure timely availability of required documentation.
• Support internal and external audits, regulatory inspections, and compliance activities.
• Ensure proper filing, traceability, retrieval, and maintenance of quality records.
• Coordinate with relevant departments to obtain documentation and ensure compliance with procedures.

Skills

QMS documentation

ISO 13485

CAPA & NCR handling

Deviations management

Complaint handling

Documentation control

MS Excel

MS Word

Attention to detail

Confidentiality

Education

B.Pharm / M.Pharm / B.Sc. / M.Sc. / B.Tech or equivalent

Tools

MS Excel

MS Word

Job description

We are looking for a detail-oriented and organised Quality Assurance & Regulatory Affairs professional to support the maintenance of the Quality Management System (QMS), documentation, production records, quality processes, and regulatory compliance activities. The candidate will be responsible for maintaining accurate quality records and supporting internal quality investigations, audits, and regulatory requirements.

Key Responsibilities

• Prepare, review, update, and maintain assigned Quality Management System (QMS) documents, procedures, formats, and records.
• Issue controlled documents and maintain document control registers and records.
• Review Batch Manufacturing Records (BMRs) and supporting production documentation for accuracy and completeness.
• Maintain and update quality-related logs and trackers, including:
• Customer Complaints
• Corrective and Preventive Actions (CAPA)
• Non-Conformities (NC)
• Deviations
• Other quality-related records.
• Maintain reference samples, stability records, and associated documentation as per established procedures.
• Support customer complaint investigations and internal quality investigations.
• Prepare, review, and update assigned regulatory and technical documentation.
• Assist in regulatory submissions and ensure timely availability of required documentation.
• Support internal and external audits, regulatory inspections, and compliance activities.
• Ensure proper filing, traceability, retrieval, and maintenance of quality records.
• Coordinate with relevant departments to obtain documentation and ensure compliance with established quality procedures.

Required Skills & Competencies

• Knowledge of Quality Management Systems (QMS) and documentation practices.
• Familiarity with ISO 13485 and applicable regulatory requirements will be an advantage.
• Basic understanding of CAPA, deviations, non-conformities, and complaint handling.
• Good documentation, record-keeping, and coordination skills.
• Proficiency in MS Office, particularly Excel and Word.
• Strong attention to detail and organisational skills.
• Ability to maintain confidentiality and meet documentation deadlines.

Educational Qualification

B.Pharm / M.Pharm / B.Sc. / M.Sc. / B.Tech or equivalent qualification in a relevant discipline.

Preferred Experience

1-3 years of experience in Quality Assurance, QMS documentation, or Regulatory Affairs, preferably in the medical devices, pharmaceutical, or healthcare manufacturing industry.