Corporate Quality Assurance Manager

Location

Ghaziabad | India

Job description

Job Description – Assistant Manager - CQA

Quality Management System and Documentation

• Designing Standard Operating Procedures/guidelines/Manual for various Business Processes of organization with inputs from Best-in-Class practices.
• Ensure that Quality/Food Safety plans are developed for all product categories and it is implemented.
• Document Control & Management for all the documents prepared under Dabur Quality Management System.
• To continuously review quality control processes, procedures and capabilities in order to sustain the most cost effective and efficient methods for meeting quality requirements, and making recommendation for improvement as appropriate.
• Establish Corporate Quality Management System (QMS) and best-in-class consumer response program.

USFDA/UL/SGS compliance

• Ensure compliance against USFDA & other audits and other RCPs.
• Ensure sites are compliant with the necessary audit requirement w.r.t infrastructure, documentation, standard testing procedure and validation. Timely CAR closures

Budgeting & Capex

• Capex planning and execution for Quality Control instruments on yearly basis for CQA.
• Vendor Negotiation for Quality Control instruments.
• Support to Unit team for centralized buying of major instruments.

Projects (Green field & Brownfield)

• Design & execution of Chemical & Microbiology labs
• Support to project team on implementation of Ayurvedic & Health care products

Product Certification

• Execution & support for product certification eg. Organic, Non GMO, Glyphosate, WHO GMP, AYUSH (Premium/Standard)

Consumer Complaint

• Daily review & closure of consumer complaints by interaction with relevant stakeholders.
• Regular interaction & training to I energizer on complaint handling.

NPD support (Ayurveda & Healthcare)

• Assessment and approval of new third parties.
• Conducting precommercial trials & commercial productions at 3Ps.
• Review & approval of NPD documents in MWT

Regulatory Compliance

• To ensure timely response to all regulatory notices in consultation with relevant stakeholders.
• Preparation of necessary documentation for notice closure w.r.t Quality.

Audits

• Scheduling of Internal & external audit (TUV) for DIL units, 3P, CFAs, Stockiest.
• Conducting audits as per schedule & Compliance of audit calendar in discussion with audit team.

Process Improvement/Optimization

• Analyze data to identify areas for Process Improvement using tools like Six Sigma Methodology, Lean Enterprise system, ISO Quality System Standards, PDCA methodology, TPM suiting to the needs of the Organization and overseeing their implementation across Company operations.
• Work as a catalyst for change and improvement in performance and quality.
• Drive the cultural transformation of site-level Quality Assurance/Quality Control (QA/QC) programs and problem solving methodologies for all manufacturing process.
• Identify process improvements that lead to cost savings or revenue enhancement opportunities.
• Manage and control all QA/QC activities in accordance with identified Quality Assurance standards, company procedures.
• To lead all SAP related activities and any new digitization projects w.r.t consumer complaints, MWT and other Quality tool.

Monitoring & Action:

• Designing and implementing a comprehensive system for Periodic monitoring of overall Quality systems and processes (farm to fork).
• Monitor and track the Company's Total Cost of Quality (COQ) factors, including product warranty costs, manufacturing scrap & obsolescence costs, and drive year-over-year improvements.
• Monitoring and review of QA/QC data, SPC for critical process and provide feedback to the user for continuous improvement.
• Create methodologies and processes for the collection and analysis of data.
• Establish the traceability system at organization level and ensure mock recall to verify the system.

MIS/Reports:

• Preparation of monthly Reports/ key highlights/MANCOM presentations.
• Prepare Unit wise Quality KPI compliance and communication of the same to the Unit.
• Analysis of data (process/other QA or QC data) and share the outcomes/inference with seniors. Collect, analyze and summarize quality control/quality assurance trends and data (e.g. SPC, machine capability), compile information into reports, and present it to seniors.
• To monitor and report QA/QC progress, notify predicted shortfall or discrepancies if any. Compilation of Factory wise regulatory compliance data for management to initiate action.

Internal Audits

• Prepare Corporate QA Audit calendars for all manufacturing site/CFA and adherence of the audit calendar.
• Study of documents like ISO, FSSC, Ayush, EHEDG, CODEX and WHO Guidelines for timely updation of auditing documents/checklists.
• Ensure that all audit records and documentation are accurate and in compliance with applicable regulations.

Training/ Knowledge Sharing:

• Develop training module for Unit QA/QC team to drive continuous improvement in product quality, manufacturing process & systems.
• Monitors and evaluates the activities of the department employees, while providing coaching, motivation, guidance and training to ensure operational efficiency and adherence to company policies and procedures.
• Thorough understanding of ISOs principles, philosophy, and auditing procedures.
• Cultivate and disseminate knowledge of quality assurance best practices.

Experience& Qualification;

• Minimum 10 years of experience in total with min 3 years in corporate quality management
• B. Tech. / M. Tech in Food Science & Technology, B.A.M.S, Masters in Pharma

Desired:

• Strong data analysis experience as well as sound knowledge of MS Office and SAP.
• Good knowledge of TPM, TQM, 5-S, KAIZEN, QC, QIT, SGA, SPC, SQC etc.
• Knowledge of Quality Control Charts, concepts and methodologies of QA.
• Knowledge of relevant regulatory requirements.

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Salary