Dy. Manager - Quality

Job Description:

Position:          Dy. Manager - Quality

Location:         Vapi

Experience:      8 - 10 Years

Industries:       Pharma API

 Responsibilities:

• Quality Management System (QMS)

•  

  Establish, implement, and maintain an effective Quality Management
• System in line with cGMP, ICH, USFDA, EU-GMP, WHO, and other regulatory requirements.
• Ensure compliance with SOPs, policies, and regulatory guidelines across manufacturing, QC, and support functions.
• Review and approve SOPs, protocols, validation documents, and quality records.
• Regulatory Compliance & Audits
• Lead regulatory inspections and customer audits (USFDA, MHRA, WHO, ANVISA, etc.).
• Ensure audit readiness of the facility at all times.
• Review observations, prepare responses, and ensure timely CAPA implementation and closure.
• Deviation, CAPA & Risk Management
• Oversee investigations related to deviations, OOS, OOT, complaints, and incidents.
• Ensure root cause analysis and effectiveness of corrective and preventive actions.
• Manage change control and risk assessment activities.
• Product Quality & Validation
• Ensure execution and review of Process Validation, Cleaning Validation, Equipment Qualification, and Analytical Method Validation.
• Review and approve Product Quality Review (PQR/APQR).
• Ensure lifecycle management of products and processes.
• Team Leadership & Training
• Lead, mentor, and develop the Quality team.
• Ensure training on GMP, data integrity, and quality systems for all employees.
• Conduct performance reviews and competency development.
• Data Integrity & Continuous Improvement
• Ensure compliance with Data Integrity principles (ALCOA+).
• Drive quality improvement initiatives and promote a quality culture.
• Implement quality metrics and management review processes.
• Cross-Functional Coordination
• Collaborate with Production, Engineering, Warehouse, Supply Chain, Regulatory Affairs, and R&D.
• Support new product introductions, technology transfers, and regulatory submissions.

Required Skills

• In-depth knowledge of cGMP, ICH guidelines, and global regulatory requirements
• Strong leadership and people management skills
• Expertise in audits, CAPA, risk management, and validation
• Excellent communication and documentation skills
• Experience with QMS and electronic documentation systems

Required Qualification: - B.Sc/M.Sc - Chemistry

Salary :- Upto 13.00 LPA

If you are interested for this opening please send updated resume same mail with following details.

Total No. of Years Experience :-

Current CTC :-

Expected CTC :-

Notice Period :-