Assistant QA QC Manager (Pune)

Assistant QA QC Manager (Pune)

01 Oct
|
ACG
|
Pune

01 Oct

ACG

Pune

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

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