Major accountabilities:

• Perform qualification assessments on analytical instruments to ensure compliance with regulatory requirements and industry standards.
• Develop and execute qualification protocols, including installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ), for analytical instruments.
• Collaborate with cross-functional teams to ensure alignment on qualification processes and requirements.
• Ensure that all qualification activities are properly documented and maintained in accordance with company policies.
• Troubleshoot any issues or discrepancies that arise during qualification and propose and implement appropriate corrective actions.
• Stay up to date with industry trends, regulations, and best practices related to analytical instrumentation qualifications, and incorporate them into the qualification processes as necessary.
• Provide technical expertise and support to internal teams relating to the qualification and maintenance of analytical instruments.
• Continuously improve the qualification processes to enhance efficiency, accuracy, and compliance.

Key performance indicators:

• Successful execution of assigned tasks within given timelines at expected quality; right first time and right in time -Adherence to appropriate standards as defined in Quality Manual, SOPs, ethical, health, safety, environment (HSE), and information security (ISEC) guidelines -Adherence to costs, quality, quantity, and timelines for all assigned tasks.
• Feedback from other team members/leaders.
• Refer to annual individual and team objective setting.
• Measurable contributions to increasing efficiency and productivity in the work related to assigned projects.

Minimum Requirements:

• B.E./B.Tech/Bachelor's or master’s degree in chemistry, Analytical Chemistry, or a related field with experience of 10 + years.
• Solid understanding of analytical instrumentation principles and technologies.
• Proven experience in qualifying and validating analytical instruments Like HPLC, GC , UV, FTIR, KFT, Balances, etc, including the development and execution of qualification protocols.
• Sound Knowledge on Software validation, software operation of CDS like Empower, Chromeleon, etc.
• Knowledge of relevant regulatory requirements and standards, such as FDA regulations and GMP guidelines.
• Strong analytical and problem-solving skills, with the ability to troubleshoot and resolve issues related to instrumentation qualification.
• Excellent documentation and record-keeping abilities, with strict attention to detail.
• Effective communication and interpersonal skills, with the ability to collaborate and liaise with cross-functional teams.
• Ability to work independently and prioritize tasks in a fast-paced environment.

Skills:

• Laboratory Equipment.
• Laboratory equipment qualification
• GMP.
• Sop (Standard Operating Procedure).
• Technical Writing.

Languages :

• English.