Sr Executive / Assistant Manager - QA (IVD)

Promea Therapeutics Pvt. Ltd.; Hyderabad; On-site; INR 800,000 - 1,200,000; Full time

Job summary

Promea Therapeutics Pvt. Ltd. is seeking a quality systems professional to ensure cGMP implementation and SOP review within the plant.

The role requires preparing and reviewing quality documents, handling deviations, incidents, change control, root cause analysis, and CAPA. The successful candidate will manage self-inspection activities and support product complaints and recalls. Responsibilities include training others, approving COA and related specifications, and ensuring master records and

Qualifications

• Proficient in cGMP systems and regulatory expectations.
• Ability to review and ensure SOP compliance and quality documents.
• Experience in CAPA, deviations, incidents, and change control processes.
• Familiarity with self-inspection practices and audit readiness.
• Experience handling complaints, recalls, and product quality issues.

Responsibilities

• Implement cGMP in the plant.
• Review SOPs for accuracy and compliance.
• Prepare and review quality documents (SMF, Quality Policy).
• Review and compile Deviations, Incidents, Change Control, and RCA.
• Review and implement CAPA effectively.
• Prepare self-inspection reports.
• Handle market complaints and product recalls.
• Provide trainings.
• Approve COA, Specifications, STPs and SOPs.
• Review Master Packing Card, Master Formula Card, Batch MBR and BPR.
• Ensure design and development meet regulatory quality standards.
• Manage risk for IVD products.

Skills

cGMP

SOP review

Quality documentation

CAPA

Root cause analysis

Self-inspection

Training delivery

Certificate of Analysis

Vendor QA review

Batch records review

Regulatory compliance

Risk management

Job description

Job ID - 1083

Job Description

1. Responsible for implementation of cGMP in the plant.

2. Responsible for review of SOPs.

3. Responsible for preparation of Quality Documents such as SMF, Quality Policy etc.

4. Responsible for review and compilation of Deviations, Incidents, Change Control and Root Cause Analysis.

5. Responsible for review and proper implementation of CAPA.

6. Responsible for conducting and preparation of Self-inspection reports.

7. Responsible for handling of Market Complaints & Product Recall.

8. Responsible for providing trainings.

9. Responsible for approval of Certificate of Analysis, Specifications, STPs and SOPs.

10.Responsible for review of approved vendor list of Raw Material & Packing Material.

11.Responsible for review of Master Packing Card, Master Formula Card, Batch Manufacturing Records & Batch Packing Records.

12.Responsible for ensuring the Design and development processes meet regulatory and quality standards.

13.Responsible for risk management associated with IVD products.