QA Manager (Vasai)

Job Description:

Position:          QA Manager

Location:         Vasai

Experience:     10 - 12 Years

Industries:       Pharma Packaging 

Responsibilities:-

• Develop, implement, and maintain a comprehensive QMS in compliance with ISO 15378, ISO 13485, EUMDR DMF and other relevant regulations.

• Manage and mentor the quality assurance team, Implement and manage a robust internal audit program to identify and address non-conformances.
• Collaborate with the procurement team to ensure that suppliers and contract manufacturers meet quality standards and compliance requirements and conduct supplier audit and assessments as necessary.
• Drive continuous improvement initiatives to enhance product quality, reduce defects, and increase process efficiency.
• Lead cross-functional teams in root cause analysis and corrective/preventive action (CAPA) implementation.
• Investigating deviations, OOS by its Root cause analysis (RCA) and follow up for implementation of appropriate CAPA.
• Oversee the complaint handling process, ensuring timely and effective resolution of customer complaints within specified time limits.
• Implement and manage risk management processes.
• Taking part in Internal audits and complying with observations with action if any.
• Initiating, evaluating & implementing change controls.
• Generating effective procedures for the preparation and implementation of quality assurance programs within all areas of safety, health and environment in the manufacturing process.
• Develop and execute regulatory strategies to ensure compliance with global medical device regulations, including but not limited to FDA (US), EU MDR (Europe), and other relevant authorities.
• Generating effective procedures for the preparation and implementation of quality assurance programs within all areas of safety, health and environment in the manufacturing process
• Providing documents to the regulatory department for Maintaining of CE technical file of medical devices & and combination products.

Required Skills:-

• Should have Excellent knowledge of EN ISO 13485 ISO 15378,
• Proven leadership and management skills with the ability to optimize team performance and development.
• Excellent analytical and problem-solving abilities
• Experience with successful regulatory submissions and approvals.

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

Salary :- Upto 13.00 LPA

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

Total No. of Years Experience :-

Current CTC :-

Expected CTC :-

Notice Period :-