Qualification : M. Sc. – Chemistry/Analytical Chemistry
Experience : Minimum 8 years of relevant Experience
The Manager – QA/QC will be responsible for ensuring compliance with GMP standards, regulatory requirements, and internal quality systems in a chemical manufacturing setup. The role involves managing quality control operations, conducting audits, ensuring proper documentation, certifying product quality, driving continuous improvement initiatives, and coordinating with cross-functional teams to maintain the highest quality standards.
Key Responsibilities:
Must Have:
1. Documentation & Regulatory Compliance
- Ensure compliance with GMP, regulatory requirements, and internal quality standards.
- Manage and organize all QC department documentation for audit readiness and accessibility.
- Handle multinational company audits in chemical plant environments.
- Maintain proper retention sample storage for each dispatch batch as per SOPs.
- Ensure regulatory documentation compliance and support regulatory affairs activities.
2. SOP & Quality Management Systems
- Identify gaps in system SOPs in coordination with the Functional Head and allocate corrective actions.
- Assist various functions in preparing and revising SOPs and quality guidelines.
- Analyze customer complaint trends and identify improvement areas.
- Conduct internal audits of records, practices, and documentation to ensure compliance with internal controls.
- Monitor and audit CAPA (Corrective and Preventive Action) effectiveness.
3. Quality Control & Manufacturing Oversight
- Audit manufacturing systems to ensure adherence to quality standards.
- Ensure timely release of raw materials for production and finished goods for dispatch.
- Escalate quality deviations to higher management or sales coordinators as required.
- Oversee IPQA/QC activities to ensure compliance with established quality protocols.
4. Product Quality Certification
- Review and certify Certificates of Analysis (COA) for each production batch.
- Validate batch documentation before product release.
5. Collaboration & Continuous Improvement
- Work closely with Production and R&D teams to meet specifications and resolve quality deviations.
- Participate in QA-related audits as a core team member.
- Monitor daily QA/QC activities to maintain compliance and performance standards.
Want Have:
1. Process Innovation:
- Innovating new methods for QC processes to improve efficiency and reduce time and efforts.
- Implementing strategies to increase and manage the life of instruments for enhanced productivity.
2. Analytical Support and Quality Assurance:
- Providing analytical support to production activities and assisting in the development of quality assurance processes.
- Conducting training sessions for new joiners on quality assurance aspects when required.
3. Process Innovation:
- Innovating new methods for QC processes to improve efficiency and reduce time and efforts.
- Implementing strategies to increase and manage the life of instruments for enhanced productivity.
4. Analytical Support and Quality Assurance:
- Providing analytical support to production activities and assisting in the development of quality assurance processes.
- Conducting training sessions for new joiners on quality assurance aspects when required.
Reporting to: Unit Head & Management