Lead Quality_Shirwal__Pharma Packaging_PVC Films/ Aluminium foils

ACG World; Pune District; Presencial; INR 1 200 000 - 1 800 000; Tempo integral

Resumo da oferta

ACG World in Pune, India, seeks a senior Quality leader to drive the Quality function, implement systems, and ensure product quality across manufacturing operations.

The role leads CAPA, customer complaints, supplier quality, and internal audits, while mentoring the quality team and shopfloor personnel. You will champion digitization, SOPs, and process controls to sustain a robust quality culture.

Qualificações

• Experience leading quality function in pharma/manufacturing.
• Strong knowledge of GMP/QA processes and CAPA systems.
• Proven ability to drive improvement and supplier quality.

Responsabilidades

• Lead customer complaint handling with effective RCA and CAPA.
• Drive external failure detection and internal quality improvements.
• Ensure alignment with customer specs and manage deviations.
• Implement and monitor quality systems, SOPs, and process controls.
• Drive digitization and standardization of quality initiatives and documents.
• Promote proactive quality culture and accountability.
• Oversee incoming material inspection and supplier quality compliance.
• Participate in new product development and supplier development.
• Lead, train, and mentor the quality team and shopfloor personnel.
• Ensure 100% inspection for critical/high-risk orders as required.
• Coordinate with departments for correct customer data and audits.
• Drive cross-functional quality improvement projects.

Conhecimentos

Quality management

CAPA

GMP

Audits

Supplier quality

Team leadership

Process improvement

Data analysis

Descrição da oferta de emprego

• Drive and lead the Quality function to ensure implementation of Quality systems, adherence to process to ensure consistent product quality
• Drive digitization , quality projects and quality culture in ACG Pharmapack.

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”
• Analyze 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.
• 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.
• 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