Manager QA/QC

Minal Specialities; India; On-site; INR 1,800,000 - 3,000,000; Full time

Job summary

Minal Specialities in India seeks a Manager – QA/QC with a strong background in GMP, regulatory compliance, and internal quality systems in a chemical manufacturing setup. The role involves leading QA/QC operations, audits, proper documentation, certifying product quality, and driving continuous improvement with cross-functional teams.

Key responsibilities include regulatory compliance, SOP and QMS improvements, IPQA/QC oversight, COA review, batch release, and collaboration with Production and

Qualifications

• M. Sc. in Chemistry/Analytical Chemistry is required.
• Minimum 8 years of relevant experience in QA/QC for chemical manufacturing.
• Experience in GMP, regulatory compliance, and internal quality systems.

Responsibilities

• Ensure GMP/regulatory compliance and internal quality standards.
• Manage QC department documentation for audits and accessibility.
• Audit multinational company chemical plant environments.
• Maintain retention sample storage as per SOPs.
• Review and certify Certificates of Analysis (COA) for production batches.
• Collaborate with Production, R&D to meet specs and resolve deviations.
• Monitor CAPA effectiveness and perform internal audits.

Skills

Documentation

Regulatory Compliance

Audits

CAPA

Quality Control

IPQA/QC

COA Review

Education

M. Sc. – Chemistry/Analytical Chemistry

Job description

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