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 current 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
📌 Assistant QA QC Manager (Pune)
🏢 ACG
📍 Pune