02 Oct
|
Weekday AI
|
Vapi
Description
This role is for one of Weekday’s clients
Salary range: Rs 1500000 - Rs 2700000 (ie INR 15 - 27 LPA)
Min Experience: 15+ years
Location: DAMAN, Vapi, Gujarat, India
JobType: full-time
We are seeking an experienced and highly capable Senior Manager – Quality Assurance (QA) with 15–25 years of experience in the pharmaceutical industry to lead and oversee quality assurance activities across manufacturing operations. The ideal candidate will have strong expertise in Sterile manufacturing and IPQA (In-Process Quality Assurance), with hands-on exposure to quality systems, regulatory compliance, manufacturing processes, and audit readiness.
The role will be responsible for ensuring that all manufacturing and quality operations comply with applicable GMP, regulatory, and internal quality standards. The candidate will work closely with Production, Quality Control, Engineering, Regulatory Affairs, and other cross-functional teams to maintain robust quality systems and drive continuous improvement.
Requirements
Key Responsibilities
- Lead and manage overall Quality Assurance activities for pharmaceutical manufacturing operations, with a solid focus on sterile products.
- Oversee IPQA activities across manufacturing areas, ensuring compliance with approved procedures, batch manufacturing records, SOPs, specifications, and GMP requirements.
- Provide QA oversight for sterile manufacturing operations, including aseptic processes, environmental monitoring, cleaning, sanitization, and contamination-control practices.
- Review and approve Batch Manufacturing Records, Batch Packaging Records, protocols, reports, SOPs, specifications, and other quality documents.
- Ensure timely investigation and closure of deviations, incidents, OOS/OOT results, CAPA, change controls, and market complaints.
- Establish and maintain effective quality systems in accordance with applicable GMP and regulatory requirements.
- Lead internal audits, customer audits, and regulatory inspection
📌 Senior Manager QA (Vapi)
🏢 Weekday AI
📍 Vapi