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Job Title: Quality Assurance Engineer

Job Summary:

The Quality Assurance Engineer is responsible for implementing and maintaining quality control processes to ensure that products meet regulatory requirements and environmental standards. The role involves working closely with cross-functional teams to identify quality issues, implement corrective actions, and drive continuous improvement in product quality and reliability.

Key Responsibilities:

1. Quality Control Processes:

• Develop and implement quality control processes and procedures for manufacturing environmental products.
• Define quality metrics and standards to ensure compliance with regulatory requirements and customer specifications.

2. Product Testing and Validation:

• Design and execute comprehensive testing protocols to validate the performance, reliability, and safety of products such as composting machines, incinerators, and other environmental equipment.

3. Regulatory Compliance:

• Ensure products comply with relevant regulatory standards and certifications such as ISO 9001, ISO 14001, and OHSAS.
• Stay updated on regulatory changes and ensure continued compliance in product design and manufacturing processes.

4. Root Cause Analysis:

• Investigate quality issues and customer complaints to identify root causes.
• Implement corrective and preventive actions using tools such as FMEA, 5 Whys, and other problem-solving techniques.

5. Documentation and Reporting:

• Maintain accurate records of quality control activities, test results, and corrective actions.
• Prepare quality reports and track metrics related to defects and non-conformances.
• Communicate quality-related insights to management, engineering teams, and production staff.

6. Training and Development:

• Provide training and guidance to production staff on quality standards, processes, and best practices.
• Promote a culture of quality, accountability, and continuous improvement across the organization.

7. Continuous Improvement:

• Lead initiatives to improve product quality, manufacturing efficiency, and quality control systems.
• Apply lean manufacturing principles and quality management methodologies to minimize waste and enhance productivity.

Qualifications & Experience:

• Bachelor’s degree in Engineering (Mechanical, Electrical, Quality, or related field).
• 1–3 years of experience in Quality Assurance, Quality Control, or a related role.
• Strong understanding of quality management principles in a manufacturing environment.
• Familiarity with standards such as ISO 9001, ISO 14001, and OHSAS.
• Experience with Quality Management Systems (QMS) and quality control processes.
• Proficiency in data analysis and problem-solving methodologies.
• High attention to detail with strong documentation and reporting skills. 

Minimum Qualifications/Experience:

1. B. Pharma, B.Sc./M.Sc. (Chemistry/Microbiology)

2. 8+ Years of experience in QA process in Pharmaceutical / food processing / cosmetics / chemical industries.

Job Responsibilities:  

C1. Principal thrust area:

You shall be responsible for maintaining and improving all QMS activity, GMP and GLP across the company.

C2. Key Deliverables:

1. Ensure manufacturing practices as per cGMP and GLP standards.

2. Handling QMS activities like change control, validations, stability, qualifications, APQR and Risk assessment etc.

3. Applications for AHC to AQCS, EIA and Capexil and coordinate related activities. (AHV/SPD: This is exclusive knowledge related to Capsule and companies manufacturing animal origin products. We have mentioned this as the candidate on joining will be responsible for this work though he/she may not be having exposure to same.)

4. Organize internal and external audits for ISO, GMP+, FDA, Capexil, GMP+, EIA and others. Maintain the documents required for those audits.

5. Organize internal and external audits for ISO, GMP+, FDA, Capexil, GMP+, EIA and others. Maintain the documents required for those audits.6. Evaluation and approval of Suppliers for RM, PM, testing labs and service providers.

7. Assisting HOD in customer complaint analysis and preparation of customer complaint report.

8. Investigation of incidents, deviations, OOS and ensure corrective actions in place.

9. Reviewing the daily availability of operators and allocating work to them.

10. Maintaining and review BMR documents, guide for relevant changes if required.

11. Label artwork review and management.

Competencies: 

D1. Technical Competencies:

a) Analytical skills (spotting trends and patterns)

b) Report writing skills

c) Problem solving abilities

d) GMP and GDP knowledge

e) Good English communication skills (verbal & written).

Behavioural Competencies:

a) Quality and Service Orientation

b) Delivering consistent results

c) Ability to prioritize, organize, manage work and time.

d) Customer Centric

e) Cross Functional Team Working

Reporting & Responsibility:

Position Reports to: Plant Head (M03)

Reportees to this position: Assistant Officer QA – M12 (2 nos)

Job Location:

1. Tarapur MIDC. Tarapur MIDC, Boisar, Dist. Palghar, Maharashtra. 

 Preference will be given to candidates in Tarapur/Boisar area or willing to relocate.

2. For outstation bachelors, Company provides a subsidized bachelor’s flat. For outstation families, Company provides subsidized accommodation in company owned buildings. Relocation allowance is offered.

3.Tarapur- Railway station Boisar takes 1.5 hrs. by train from Borivali Station or by road via Western Express Highway.   

4. Suburban local trains direct from Churchgate to Boisar Railway station available.

G. What’s in it for You:

1. Opportunity to be part of a growing organization offering niche products to Pharma industry.

2. Opportunity to work at Head Office location.

3. Intimate small company culture with MNC professionalism.

4. Company value programs TrANSSCEnD.

5. Employee events like festival celebrations, family fun events etc.

6. Five days working (alternate weeks).

7. Medical Insurance for your immediate family.

8. Housing accommodation for Bachelors & family.