Manager Quality Assurance | Gufic | Navsari

Job Description

Roles and Responsibilities

• Develop, implement, manage, audit and maintain GMP quality systems.
• Coordinate and perform all vendor qualification and compliance audits.
• Develop, manage and maintain a GMP compliant document control system.
• Oversee investigations of all non-conformances (deviations, errors etc.).
• Ensure that cGMP requirements and quality standards are recognized, understood and maintained across the Company.
• Work across all disciplines (e.g. manufacturing, warehouse & QC, etc.) to ensure that the Company maintains a state of readiness for inspection by regulatory agencies.
• Keep abreast of changes to quality regulations and guidelines, advising the management team of any business implications of these changes. Lead, manage and ensure proper training to any relevant change management programs throughout the company.
• Provide quality guidance to product development projects and programs.
• Maintaining and improving departmental operational performance, to meet the requirements of regulatory authorities, company Standard Operating Procedures (SOPs) and external and internal customers, with respect to quality, service, lead time and cost.
• Ensuring the development of departmental SOPs (writing, revising and approving), ensuring regulatory compliance in conjunction with being – fit for purpose- operationally and commercially.
• Ensuring that all activities are performed in accordance with GMP, company SOPs and Health and Safety policies.

Desired Candidate Profile

Experience in injectable plant is a must

Qualification: M.Pharma

Experience: 15-16 Years

Salary: Negotiable