Quality Assurance Officer

Africure Pharmaceuticals (I) Pvt Lt; Palghar; On-site; INR 600,000 - 900,000; Full time

Job summary

Africure Pharmaceuticals (I) Pvt Lt in Palghar Plant seeks a quality management professional to lead QMS, SOP implementation, and regulatory compliance. You will ensure daily documentation, drive audits, and oversee BMR and batch release processes to maintain audit readiness.

You will train and develop the team to meet deliverables, addressing OOS events and recalls, while generating MIS for management review.

Qualifications

• Quality Management Systems ownership and oversight in the department.
• SOP management and implementation of corporate quality guidelines.
• Maintain updated departmental documentation meeting regulatory requirements.
• Train and develop manpower to achieve deliverables.
• Periodic audits and self-inspections to stay 100% audit-ready for cGMP.
• Handle BMR, Batch release, OOS and product recalls.
• Generate relevant MIS reports.

Responsibilities

• Own and ensure effective QMS across the department.
• Implement and monitor SOPs aligned with quality guidelines.
• Ensure daily documentation updates and regulatory compliance.
• Train staff to enhance capability and output.
• Coordinate internal audits and ensure readiness for external audits.
• Oversee BMR, batch release, OOS and recalls as required.
• Produce accurate management information systems reports.

Skills

Quality Management Systems

SOP Management

Regulatory Compliance

Documentation Control

Audits & Self-Inspection

Team Training & Development

Education

B.Pharm / M.Pharm

Job description

Role & responsibilities

Responsible and Accountable for all Quality Management Systems in the department.

SOP management and implementation of the corporate quality guidelines in the department.

Ensure that all departmental documentation is updated daily and all regulatory and statutory requirements are complied with.

Ensure optimum usage of manpower resources and train and develop them to achieve their deliverables.

Periodic Audits and self inspection of the department to ensure that all the requirements of cGMP are maintained and that the plant is always 100% audit ready.

Operational matters such as BMR and Batch release, OOS and product complaints/ Recalls.

Generate relevant and accurate MIS.

Preferred candidate profile

Qualification: B.Pharm / M.Pharm
Experience: 3-4 years of relevant experience in Pharmaceutical

Production; OSD experience preferred.
Knowledge of GMP, QMS & Audit Readiness.
Location: Palghar Plant