3+ FDA Jobs in India

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.

Job Title : Medical Device Engineer

Location : Bangalore / Pune

Experience : 5+ Years total, with at least 3 years in Medical Device Development, Sustenance, or DHF Remediation

Notice Period : Immediate to 1 week

Interview Process : L1-selected candidates will undergo a customer interview

Mandatory Skills : Medical Device Development/Sustenance/DHF Remediation, ISO 13485, IEC 60601, ISO 14971, FDA & EU MDR compliance, DHF documentation, Design FMEA, CTS/CTQ, QMS, PLM, Verification & Validation, Impact Assessment.

Key Skills & Knowledge :

• Strong understanding of ISO 13485, IEC 60601, and ISO 14971 standards
• Experience with FDA and EU MDR regulatory requirements

Responsibilities :

• Conduct gap assessments and create/update DHF documents, including user and product requirements, design FMEA, CTS/CTQ, and standards compliance reports
• Analyze and implement design changes, assess impact, and update documentation accordingly
• Identify gaps in verification and validation, ensuring clear traceability between requirements and verification documents
• Assess compliance with applicable standards and regulations
• Define CTS/CTQ parameters and actively participate in design reviews
• Follow QMS guidelines and manage changes through PLM.

Job Title: QA Associate 

Job Description:

1. Responsible for Implementing, controlling and monitoring quality management system documentation (ISO 27001) and data privacy (SOC2).
2. Coordinate improvement in the system through output from audit, management review, and responsible to close NC’s during audits.
3. Knowledge of SAMD (Software as Medical Device) SaaS product, processes and procedures.

3-5 years of relevant experience in Medical Devices Industry.

Area of Expertise:

• To generate, implement and maintain internal quality procedures and systems to comply with ISO 27001, SOC2 standards
• Maintaining and updating various documents like internal docs log, external log, , Obsolete docs log, DCN, ECN, CAPA, SQA/IQA log, product complaint, equipment log
• Maintaining Engineering documents like part specs, Bill of materials, Drawings, Design review documents etc
• Co-ordinate and conduct periodic internal audits of various functional groups of an organization and drive compliance to QMS.
• Manage all documentation related to internal and external audit.
• Manage all the documents related to supplier qualification and coordinate Supplier’s audit and maintain the supplier file.
• Experience in Handling of CAPA (Corrective & Preventive Actions) & Product Complaints
• Co-ordination of Management Review Meetings & its action items implementation

Experience Required:

• 3-5 years of relevant experience in Medical Devices Industry.
• Educational Qualification – Diploma/Engineering graduate, preferably Computer Science or related.
• Ability to read and understand standard requirements independently.
• Good teamwork, communication and interpersonal skills. A demonstrated commitment to company values
• Good understanding of design control, and post marketing processes
• Knowledge of FDA / EU / Indian & other national regulations is an added advantage.
• Working knowledge of an e-QMS is an added advantage.