QA Manager

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 13485, 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:-

   •  Excellent knowledge of EN ISO 13485 ISO 15378,
   •  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 11.00 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 :-