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Novartis Hiring for Technical Steward – Devices in Hyderabad: Drug Delivery Systems
Position Overview & Specifications
| Parameter | Official Specifications |
|---|---|
| Hiring Organization | Novartis Healthcare Private Limited (Global Service Center) |
| Designation / Track | Technical Steward – Medical Devices & Drug Delivery Systems |
| Target Qualifications | B.Pharm, M.Pharm, B.Tech / M.Tech Biomedical / Mechanical Engineering |
| Experience Profile | 3 to 7 Years Experience |
| Core Focus | Combination Products, Risk Management ISO 14971, Design Controls & Technical Transfers |
| Work Location | Hyderabad (Office-based), Telangana |
| Application Mode | Direct Official Novartis Workday Global Requisition |
Verified Vacancy Matrix & Hiring Tracks
Review all active hiring tracks below. Direct official application links for each position are provided at the bottom of this notification:
| # | Designation & Hiring Track | Work Location | Experience & Mode |
|---|---|---|---|
| 1 |
#1Technical Steward – Medical Devices & Drug Delivery
Technical Operations & Device Quality Assurance |
Location: Hyderabad
|
Experience: 3 – 7 Yrs Online Portal
|
Key Roles & Detailed Responsibilities
- Prepare, compile, and review regulatory dossiers (eCTD format Module 1-5) for submission to global health authorities (USFDA, EMA, MHRA, CDSCO) on behalf of Novartis.
- Coordinate with plant QC/QA and R&D teams to gather technical chemistry, manufacturing, and control (CMC) documentation and stability updates.
- Track regulatory deficiency letters, manage query responses within agency timelines, and ensure lifecycle maintenance of approved marketing authorizations.
- Ensure compliance with updated pharmacopoeial monographs, labeling guidelines, and country-specific variation filing mandates.
Eligibility Criteria & Candidate Profile
- Academic Qualifications: Candidates must possess B.Pharm, M.Pharm, B.Tech / M.Tech Biomedical / Mechanical Engineering from an accredited university or approved technical institution.
- Experience Profile: 3 – 7 Years Experience with demonstrated hands-on technical proficiency in target operational workflows.
- Regulatory & Quality Knowledge: Solid foundational awareness of pharmaceutical compliance (cGMP, ICH-GCP, GLP, 21 CFR Part 11, or CDSCO standards).
- Core Competencies: Excellent analytical problem-solving skills, rigorous documentation hygiene, and strong verbal/written technical communication.
Core Technical Competencies & Instruments Matrix
Candidates possessing hands-on proficiency across the following analytical tools, software systems, and regulatory standards will receive priority evaluation:
Quality Management System (QMS – TrackWise / MasterControl)Deviation & Incident Management WorkflowCorrective & Preventive Action (CAPA Lifecycle & Effectiveness)Change Control Management & Cross-Functional Impact AssessmentIn-Process Quality Assurance (IPQA) Line Clearance ProtocolsAnnual Product Quality Review (APQR / PQR Reporting)USFDA / MHRA / EU cGMP Compliance (21 CFR Part 210/211)Cleaning & Process Validation Protocols & ExecutionBatch Manufacturing & Packaging Record (BMR/BPR) Technical ReviewVendor Qualification & Internal Facility Compliance Audits
Daily Operational Workflow & Core Shift Duties
Detailed technical breakdown of standard shift activities, laboratory/plant floor execution, and daily operational deliverables for Technical Steward – Medical Devices & Drug Delivery:
Duty 1IPQA Line Clearance & Area Handover
Physically inspecting manufacturing suites, compression presses, blister lines, and verifying zero residue and valid cleaning tags before line clearance sign-off.
Duty 2In-Process Quality Sampling & Verification
Performing periodic in-process checks (tablet hardness, thickness, friability, weight variation, seal integrity, and strip leak test).
Duty 3Deviation & Incident Investigation
Logging non-conformances in enterprise QMS (TrackWise), categorizing severity (Minor/Major/Critical), and initiating Root Cause Analysis (RCA) with cross-functional teams.
Duty 4Batch Record (BMR/BPR) Technical Audit
Performing rigorous page-by-page audit of executed manufacturing and packaging records, reconciliation numbers, and analytical release reports prior to QP release.
Duty 5Change Control & CAPA Tracking
Facilitating risk assessments for proposed facility/equipment changes and tracking CAPA effectiveness verification at 3 to 6 months post-implementation.
Regulatory & Quality Compliance Framework
Candidates must demonstrate operational awareness and rigorous adherence to the following regulatory chapters and international standards governing this role:
USFDA 21 CFR Part 210/211
Finished Pharmaceutical cGMP
Defines minimum current good manufacturing practices for methods, facilities, and controls for drug manufacturing.
ICH Q9 (R1) & ICH Q10
Risk Management & Quality Systems
Systematic approach to quality risk management (FMEA, HACCP) and comprehensive pharmaceutical quality system lifecycle.
Schedule M (Revised)
Indian cGMP Premises & Equipment
Statutory Indian regulatory framework governing plant design, environmental classification, and self-inspection.
WHO Technical Report Series
Global GMP Guidelines
International standards for sterile pharmaceutical manufacturing, validation, and cross-contamination control.
Tailored Resume Guidelines for Technical Steward – Medical Devices & Drug Delivery
- Highlight Core Technical Instrumentation & Software: Explicitly mention hands-on software platforms (Empower 3, SAS, Argus, EDC Rave) or laboratory equipment relevant to Technical Steward – Medical Devices & Drug Delivery at the top of your resume.
- Quantify Accomplishments & Throughput: Instead of passive duty descriptions, quantify measurable deliverables (e.g., ‘Validated 15+ analytical methods per ICH Q2’, ‘Processed 120+ clinical safety ICSRs per month’, ‘Supervised 50+ commercial batches with zero deviations’).
- Standardize on ATS-Friendly Clean Formatting: Use standard single-column reverse-chronological format with clean bullet points. Strictly avoid multi-column layouts, graphics, icons, or text boxes that confuse automated enterprise ATS parsers.
- Calibrate Regulatory Terminology: Integrate exact industry compliance acronyms (e.g., cGMP, ICH-GCP, ALCOA+, 21 CFR Part 11, USFDA audit readiness) naturally throughout your project and experience narratives.
Technical Interview Assessment & Guidance
Q: What is the procedural methodology for executing a Root Cause Analysis (RCA) and implementing a CAPA for a critical deviation?
Authoritative Answer: When a critical deviation occurs, immediate containment actions are taken to quarantine affected batches. An RCA investigation is conducted using structured tools such as the ‘5 Whys’ methodology, Fishbone (Ishikawa) diagram, and Failure Mode and Effects Analysis (FMEA) to identify whether the breakdown stems from Man, Machine, Method, Material, or Measurement. Once the genuine root cause is verified, a Corrective Action is implemented to eliminate the immediate non-conformance, and a Preventive Action is designed (e.g., engineering interlock, procedural SOP revision, or targeted training) to prevent recurrence. A CAPA effectiveness check is scheduled at 3 to 6 months post-closure.
Authoritative Answer: When a critical deviation occurs, immediate containment actions are taken to quarantine affected batches. An RCA investigation is conducted using structured tools such as the ‘5 Whys’ methodology, Fishbone (Ishikawa) diagram, and Failure Mode and Effects Analysis (FMEA) to identify whether the breakdown stems from Man, Machine, Method, Material, or Measurement. Once the genuine root cause is verified, a Corrective Action is implemented to eliminate the immediate non-conformance, and a Preventive Action is designed (e.g., engineering interlock, procedural SOP revision, or targeted training) to prevent recurrence. A CAPA effectiveness check is scheduled at 3 to 6 months post-closure.
Q: What are the critical checkpoints verified during an IPQA Line Clearance before manufacturing or packaging commences?
Authoritative Answer: IPQA Line Clearance ensures zero cross-contamination and mix-up between consecutive batches. Checkpoints include: complete removal of prior product materials, labels, and waste; verification of equipment cleanliness tags with valid cleaning expiry dates; verification of room environmental parameters (temperature, relative humidity, and differential pressure); calibration status of in-line checkweighers, metal detectors, and vision systems; and sign-off on the issuance of the correct Batch Manufacturing/Packaging Record (BMR/BPR).
Authoritative Answer: IPQA Line Clearance ensures zero cross-contamination and mix-up between consecutive batches. Checkpoints include: complete removal of prior product materials, labels, and waste; verification of equipment cleanliness tags with valid cleaning expiry dates; verification of room environmental parameters (temperature, relative humidity, and differential pressure); calibration status of in-line checkweighers, metal detectors, and vision systems; and sign-off on the issuance of the correct Batch Manufacturing/Packaging Record (BMR/BPR).
Q: How do you evaluate and classify a proposed Change Control in a cGMP manufacturing facility?
Authoritative Answer: Proposed changes are classified as Minor, Moderate, or Major based on their potential impact on product quality, safety, identity, and regulatory filings. The QA change control owner facilitates a cross-functional risk assessment involving Engineering, Production, R&D, and Regulatory Affairs. If a change involves critical process parameters (CPP), critical quality attributes (CQA), or regulatory dossier commitments, validation protocols (e.g. 3 consecutive batches) and regulatory authority notification (e.g. CBE-30 or Prior Approval Supplement) are completed before QA gives final commercial implementation approval.
Authoritative Answer: Proposed changes are classified as Minor, Moderate, or Major based on their potential impact on product quality, safety, identity, and regulatory filings. The QA change control owner facilitates a cross-functional risk assessment involving Engineering, Production, R&D, and Regulatory Affairs. If a change involves critical process parameters (CPP), critical quality attributes (CQA), or regulatory dossier commitments, validation protocols (e.g. 3 consecutive batches) and regulatory authority notification (e.g. CBE-30 or Prior Approval Supplement) are completed before QA gives final commercial implementation approval.
Mandatory Documents Checklist for Interview & Verification
Ensure you organize the following original credentials and self-attested photocopies for technical interviews and HR onboarding verification:
Curriculum Vitae (2 Hard Copies)
Updated, clean chronological CV featuring core instrumentation, software tools, and role-relevant achievements.
Updated, clean chronological CV featuring core instrumentation, software tools, and role-relevant achievements.
Academic Certificates & Marksheets
Original and self-attested copies of 10th, 12th, Graduation, and Post-Graduation marksheets and degree certificates.
Original and self-attested copies of 10th, 12th, Graduation, and Post-Graduation marksheets and degree certificates.
Government Photo Identification
Original Aadhaar Card and PAN Card (mandatory for statutory PF/ESI registration) plus Passport or Driving License.
Original Aadhaar Card and PAN Card (mandatory for statutory PF/ESI registration) plus Passport or Driving License.
Past 3 Months Salary Slips & Bank Records
Official payslips and corresponding bank statement records validating salary credits (for experienced candidates).
Official payslips and corresponding bank statement records validating salary credits (for experienced candidates).
Relieving & Appointment Letters
Appointment letter and latest increment letter from current firm, plus relieving letters from all prior employers.
Appointment letter and latest increment letter from current firm, plus relieving letters from all prior employers.
Passport Photographs & Professional Registration
4 recent passport-size color photographs, plus State Pharmacy Council registration certificate (where applicable).
4 recent passport-size color photographs, plus State Pharmacy Council registration certificate (where applicable).
Frequently Asked Questions (FAQ)
Q: What is the official application procedure for Technical Steward – Medical Devices & Drug Delivery at Novartis?
Answer: Candidates must review the specified academic qualifications and functional criteria, calibrate their CV, and submit applications directly through Novartis’s official career ATS portal or designated HR application channel provided at the bottom of this notification.
Answer: Candidates must review the specified academic qualifications and functional criteria, calibrate their CV, and submit applications directly through Novartis’s official career ATS portal or designated HR application channel provided at the bottom of this notification.
Q: What academic backgrounds and degrees are eligible for this hiring drive?
Answer: Eligible qualifications include B.Pharm, M.Pharm, B.Tech / M.Tech Biomedical / Mechanical Engineering. Both entry-level and experienced professionals matching the functional tracks are eligible to apply.
Answer: Eligible qualifications include B.Pharm, M.Pharm, B.Tech / M.Tech Biomedical / Mechanical Engineering. Both entry-level and experienced professionals matching the functional tracks are eligible to apply.
Q: What is the typical interview and shortlisting workflow?
Answer: The recruitment process consists of profile shortlisting by talent acquisition, technical evaluations focusing on analytical and regulatory knowledge, and a formal HR discussion followed by academic/employment verification.
Answer: The recruitment process consists of profile shortlisting by talent acquisition, technical evaluations focusing on analytical and regulatory knowledge, and a formal HR discussion followed by academic/employment verification.
Related Career Pathways & Functional Specializations
Associated functional specializations and recruitment tracks for Technical Steward – Medical Devices & Drug Delivery at Novartis:
Novartis Recruitment 2026Novartis Careers IndiaNovartis Technical Steward – Medical Devices & Drug Delivery VacancyTechnical Steward – Medical Devices & Drug Delivery Jobs in Hyderabad, TelanganaPharma Industry Career OpeningsLife Sciences Corporate Jobs IndiaClinical Research Vacancies 2026Healthcare Corporate Careers IndiaB Pharmacy Jobs 2026M Pharmacy Pharmacology CareersPharma Jobs in Hyderabad, TelanganaPharma Speed Post Verified Careers100% Free Pharma Job Portal
Application Procedure
- Carefully review the functional eligibility criteria, academic qualifications, and key duties specified for Technical Steward – Medical Devices & Drug Delivery at Novartis above.
- Calibrate your resume to highlight relevant instrumentation, software platforms, or cGMP/GCP regulatory compliance.
- Ensure your contact details, active mobile number, and email address are up to date in your CV.
- Click the official application button below to access the direct employer recruitment portal or HR email channel with zero intermediary charges.
Submit Official Application – Technical Steward – Medical Devices & Drug Delivery at Novartis
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