Senior Manager QA

Weekday AI (YC W21); Daman; On-site; INR 1,500,000 - 2,700,000; Full time

Job summary

Weekday AI (YC W21) seeks an experienced Senior Manager – Quality Assurance to lead sterile manufacturing QA and IPQA activities in our DAMAN facility. You will drive GMP compliance, review critical quality documents, and manage audits and CAPA programs with cross-functional teams.

The ideal candidate has 15–25 years in QA within pharma, strong leadership, and hands-on experience with sterile processes, regulatory inspections, and quality systems.

Qualifications

• 15–25 years of relevant experience in Quality Assurance within the pharmaceutical industry.
• Strong experience in sterile manufacturing and IPQA is essential.
• Prior experience in a managerial or senior QA leadership position is preferred.

Responsibilities

• Lead QA and IPQA for pharmaceutical manufacturing operations, with a focus on sterile products.
• Oversee IPQA across manufacturing areas, ensuring GMP compliance.
• Provide QA oversight for sterile manufacturing operations, including aseptic processes and environmental monitoring.
• 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, CAPA, change controls, and market complaints.
• Establish and maintain robust quality systems in accordance with GMP and regulatory requirements.
• Lead internal audits, customer audits, and regulatory inspections, ensuring timely closure of observations.
• Monitor quality metrics and identify trends, risks, and opportunities for improvement.
• Collaborate with cross-functional teams to resolve quality-related issues.
• Mentor and develop QA/IPQA teams to uphold compliance and quality excellence.

Skills

Sterile Manufacturing

IPQA

GMP & Regulatory Compliance

Deviation Management

CAPA & Change Control

Documentation & Batch Review

Audits (Regulatory & Internal)

Leadership & Team Management

Analytical & Problem-solving

eQMS

Education

Bachelor’s or Master’s in Pharmacy, Pharmaceutical Sciences, Chemistry, Microbiology

Tools

eQMS

Job description

Job 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.

Key Responsibilities

• Lead and manage overall Quality Assurance activities for pharmaceutical manufacturing operations, with a strong 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 inspections, ensuring appropriate preparation, response, and timely closure of observations.
• Monitor quality metrics and identify trends, risks, and opportunities for continuous improvement.
• Collaborate with Production, QC, Engineering, Validation, and Regulatory teams to resolve quality-related issues.
• Ensure effective implementation of CAPA, change management, risk assessment, and quality improvement initiatives.
• Mentor, develop, and manage QA and IPQA teams, promoting a strong culture of compliance, ownership, and quality excellence.
• Participate in process validation, cleaning validation, qualification, and other quality-related activities where required.
• Ensure appropriate training and qualification of QA personnel and manufacturing staff on GMP and quality procedures.

Must-Have Skills

• Sterile Manufacturing / Sterile Pharmaceutical Operations
• IPQA (In-Process Quality Assurance)
• Strong knowledge of GMP, Quality Management Systems, and regulatory compliance
• Experience in deviation management, CAPA, change control, and investigations
• Strong understanding of documentation and batch review processes
• Experience handling regulatory, customer, and internal audits
• Strong leadership and team management capabilities
• Excellent analytical, problem‑solving, and decision‑making skills

Good-to-Have Skills

• Experience in Injectables manufacturing and quality operations
• Exposure to aseptic processing and contamination‑control strategies
• Experience with regulatory inspections and international GMP standards
• Knowledge of validation and qualification activities
• Experience with electronic Quality Management Systems (eQMS)

Qualifications & Experience

• Bachelor’s or Master’s degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Microbiology, or a related discipline.
• 15–25 years of relevant experience in Quality Assurance within the pharmaceutical industry.
• Strong experience in sterile manufacturing and IPQA is essential.
• Prior experience in a managerial or senior QA leadership position is preferred.

Requirements: