02 Oct
|
Vaishnodevi Melange Estates
|
Bengaluru
02 Oct
Vaishnodevi Melange Estates
Bengaluru
Role & responsibilities
1. Quality Management System
- Develop, implement, and maintain the Quality Management System (QMS).
- Ensure compliance with ISO, GMP/GDP, customer, regulatory, and internal quality requirements, as applicable.
- Establish quality policies, procedures, SOPs, specifications, and quality standards.
- Conduct periodic review and improvement of the QMS.
- Lead internal, customer, and regulatory audits.
2. Quality Control
- Oversee inspection, testing, sampling, and release activities.
- Ensure raw materials, in-process materials, finished products, and packaging materials meet approved specifications.
- Review and approve test results, analytical reports, inspection reports, and Certificates of Analysis (CoA).
- Ensure proper handling of OOS/OOT results and laboratory investigations.
- Monitor calibration, qualification, and maintenance of testing equipment.
3. Quality Assurance
- Review and approve SOPs, specifications, protocols, reports, and validation documents.
- Manage deviations, CAPA, change controls, complaints, and quality incidents.
- Ensure proper root-cause analysis and timely closure of CAPA.
- Establish and monitor quality KPIs and metrics.
- Ensure data integrity and proper documentation practices.
4. Audits & Compliance
- Plan and conduct internal quality audits.
- Coordinate customer, supplier, certification, and regulatory audits.
- Prepare teams for external inspections and ensure timely responses to observations.
- Track audit findings and verify effectiveness of corrective actions.
- Ensure compliance with applicable statutory and regulatory requirements.
5. Supplier & Vendor Quality
- Qualify and periodically evaluate suppliers.
- Review supplier quality performance and audit suppliers when required.
- Manage supplier deviations, complaints,
and corrective actions.
- Monitor incoming material quality and supplier-related issues.
6. Team Management
- Lead and manage the QA/QC team.
- Define responsibilities, targets, and performance objectives.
- Conduct training and competency assessments.
- Allocate manpower and resources according to operational requirements.
- Mentor QA/QC engineers, officers, analysts, and inspectors.
- Conduct performance reviews and identify development needs.
7. Cross-Functional Responsibilities
- Work closely with Production, Engineering, R&D;, Regulatory, Supply Chain, Procurement, and EHS.
- Provide quality inputs for new products, processes, equipment, and projects.
- Participate in NPD, process validation, qualification, technology transfer, and continuous improvement.
- Resolve quality issues with cross-functional teams.
8. Management Responsibilities Senior Manager Level
A Senior Manager generally has broader responsibility for:
- Overall QA/QC strategy and governance.
- Quality budget and resource planning.
- Departmental objectives and annual quality plans.
- Management review and quality performance reporting.
- Risk management and quality improvement programs.
- Escalation and resolution of critical quality issues.
- Regulatory/customer relationship management.
- Building a strong quality culture across the organization.
Preferred candidate profile
- Bachelors or Master’s degree in Quality Management,
Engineering, Science, Pharmacy, Chemistry, or a relevant discipline, depending on industry requirements.
- 8–15+ years of relevant experience in QA/QC, with demonstrated experience in a manufacturing, process, pharmaceutical, chemical, engineering, or other regulated environment.
- Proven experience in quality management systems, quality control, audits, CAPA, deviations, change control, root-cause analysis, and continuous improvement.
- Strong knowledge of applicable ISO standards, regulatory requirements, customer specifications, and industry quality standards.
- Experience in managing internal, customer, supplier, certification, and regulatory audits.
- Strong understanding of quality risk management, documentation, data integrity, validation/qualification, and compliance requirements, as applicable.
- Demonstrated ability to lead, develop, and motivate QA/QC teams.
- Solid analytical, problem-solving, decision-making, and communication skills.
- Ability to work effectively with Production, Engineering, R&D;, Procurement, Supply Chain, Regulatory, and other cross-functional teams.
- Experience in developing and monitoring quality KPIs, dashboards, and management reports.
- Strong leadership skills with the ability to manage multiple priorities and drive timely closure of quality issues.
- Proficiency in MS Office and relevant Quality Management/Laboratory Management systems or ERP platforms.
- Candidates with relevant professional certifications such as ISO Lead Auditor, Six Sigma, Quality Management, or other industry-specific certifications will be preferred.
- Strong commitment to quality culture, compliance, customer satisfaction, continuous improvement, and operational excellence.
📌 QA QC Manager (Bengaluru)
🏢 Vaishnodevi Melange Estates
📍 Bengaluru