Process Lead - Quality Control

• Responsible for overseeing and leading quality control processes and projects within the department, ensuring that products meet quality standards and regulatory requirements. The role involves process optimization, managing QC projects, and coaching and guiding the team.
• Develop, implement, and maintain QC processes to improve efficiency and product quality.
• Analyze current QC processes and propose improvements to optimize performance.
• Coordinate with cross-functional teams, including R&D, regulatory affairs, production, and compliance.
• To manage maintenance/trouble shooting activities for QC related instruments/systems. To manage related communication with the suppliers and the stakeholders.
• To manage documentation team, which is responsible for SOP revision, training, and sample receiving.
• Ensure that all products meet internal and external quality standards.
• Conduct audits and inspections to maintain compliance with regulatory requirements.
• Coach, guide and train QC staff to ensure a high level of competency and motivation.
• Analyze quality data to identify trends and areas for improvement.
• Prepare and present reports on QC activities and project progress to management.
• Ensure adherence to industry regulations and standards (current regulatory & cGMP requirements).
• To adhere with the cGMP principles (premises, personal, equipment, documentation, QMS and audit) and to maintain them in an effective manner.
• To check and ensure proper usage of all the QC equipment.
• To train the QC personnel on all the applicable procedures, specifications, testing methods and qualify analysts to perform various QC analysis.
• To train the QC personnel on all the applicable procedures, specifications, testing methods and qualify analysts to perform various QC analysis.
• To ensure the analysis is performed correctly as per applicable procedures and the raw data is checked for correctness, accuracy and compliance.
• To perform investigation for the lab incidents, OOS, OOL results, deviations and take appropriate corrective and preventive actions.
• Follow up &close all the EQMS actions (CAPA, OOS, Deviations, CC)
• To involve and support external and internal audits and to close the audit observations on time.

• Apart from the above, the works assigned by the Head of the department/designee.

• In terms of Competency, you are highly oriented with a strong sense of accountability & ownership,
• Excellent communication, interpersonal and presentation skills.
• Technical Competencies: In-depth knowledge of the industry's standards and regulations guidelines excellent knowledge of reporting procedures and record keeping, must have experience in handling Regulatory Authorities audits and questions and accordingly set up the action plan
• Having an Analytical mind with ability to think diversely and understand the big picture, Methodical and diligent with outstanding planning abilities, an analytical mind able to "see" the complexities of procedures and regulations
• Capable of suggesting ideas in a structured manner and having good command on English language.
• High on communication and collaboration, having an ability to manage multiple stakeholders at a time.
• Strong eye for details, having expertise to understand, review and implement the compliance inputs from Quality point of view.
• In-depth knowledge of the industry's standards and regulations guidelines, excellent knowledge of reporting procedures and record keeping.
• Must be able to manage tasks and priorities and easily adapt to changing situations.
• Ability to create cross functional relations and manage conflicts.
• Problem Solving and high agility on taking right scientific decisions.

• Minimum 7 years of experience in QC/QA department.
• Must be experienced in managing complex and sensitive operational challenges.
• Bachelor's degree in chemistry or pharmacy
• Proven experience in quality control
• Strong knowledge of regulatory requirements and quality standards relevant to the industry.
• Excellent analytical, problem-solving, and decision-making skills.
• Strong leadership and team management capabilities.

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