Assistant QA QC Manager

A. Job Objective

• Drive and lead the Quality function to ensure implementation of Quality systems, adherrance to provcess to ensure consistent product quality
• Drive digitisation , quality projects and quality culture in ACG Pharmapack.

B. Primary responsibilities

Core Functional

• Lead customer complaint handling and ensure timely closure with effective RCA and CAPA
• Drive initiatives to convert external failures into internal detections
• Ensure alignment with customer specifications and manage deviations with proper approvals
• Implement and monitor quality systems, SOPs, and process controls
• Drive standardization and digitization initiatives in Quality like Golden batch, PPR for all processes, statistics on quality parameters and control charts and documents management systems.
• Promote a culture of proactive quality and accountability
• Ensure robust incoming material inspection and supplier quality compliance
• Ensure actively participate in new product development of new raw material and keep a close eye on new product introduction in system.
• Lead, train, and mentor the quality team and shopfloor personnel
• Implement 100% inspection for critical/high-risk orders as required
• Build a strong quality culture focused on accountability and “First Time Right”
• Analyse trends and implement preventive actions
• Conduct regular process audits on shopfloor to ensure adherence to defined standards
• Initiate and lead cross-functional quality improvement projects
• Identify gaps and drive continuous improvement initiatives for process robustness
• Focus on reducing COPQ, improving First Time Right (FTR), and enhancing process capability
• Ensure strict adherence to PPR (Process/Product Requirements) across all stages
• Strengthen incoming quality through supplier evaluation and development
• Drive supplier corrective actions and performance improvement
• Conduct regular training programs for shopfloor teams and new joiners
• Drive standardization and harmonization of quality practices across all sites
• Ensure uniform implementation of systems, processes, and quality benchmarks
• Monitor effectiveness of CAPA against internal/external rejection to reduce COPQ percentage against APPL revenue.
• Coordinate with concerned departments for the correctness of customer required data.

Core Functional

• Ensure supplier development to achieve supplier self-certification.
• Interact with customers to resolve their queries and provide required documentation.
• Conduct brainstorming sessions to analyse customer complaints and provide CAPA to customers.
• Conduct risk analysis of product / process and equipment against customer complaint or during development of new product.
• Ensure preparedness for external audits (customer and regulatory) participate in critical audits.
• Prepare comparative study of various quality parameters with domestic and international leaders and recommends benchmarks.
• Ensure development and upgradation of vendors as per specific requirements
• Makes specific improvements basis an in-depth examination of quality standards through analysis of data/trends of test results and regular interactions.
• Ensure that current versions of SOPs/ WIs/ formats are available at all points of use and provide updated documents wherever required.

Internal Processes

• Drive system in such a way that we are improving processes to improve internal defects detection than external failure / customer complaints
• Define the quality assurance and quality control (QA/ QC) norms to ensure all related activities adhere to the expected quality standards and processes.
• Organise cross functional meeting with stakeholders for all the internal and external defects improvement.
• Organize inspections for each step of the process (in process, final) as per the defined quality plan to avoid errors and customer complaints.
• Organize testing of raw materials in prescribed manner within lead time for each raw material.
• Improve supplier score and ensure good quality raw material in maintained all time for the production
• Lays out a process for ensuring continuous improvement.

People development

• Serve as the point of contact for expertise on the specific area and leads capability building efforts to strengthen understanding related to pharma quality standards of team.
• Ensures completion of team IDP’s.
• Take overall responsibility for people development initiatives and building up in-house capabilities for the employees in the department

Drive a performance driven culture in the team by timely monitoring, review of performance parameters and feedback to the team members