Quality & Operations Leadership

Shwetha N

Deputy Manager – R&D · 16+ Years in Pharma & Petrochemical Manufacturing

Combining quality discipline, operational insight and technical depth to drive compliant, efficient and profitable outcomes — across QA, QC, QMS, audits, validation, Six Sigma and cost optimisation.

SN
16+Years experience
$77KAnnual savings delivered
80+Projects led
0Major audit NCs
5Global MNCs
About

Quality that drives business outcomes

As a Quality & Operations professional with 16+ years across pharmaceutical and industrial/petrochemical sectors, I bring a strong foundation in QA, QC, QMS, production support and process improvement. In my current role I delivered $77K in annual savings across 80 projects, contributed to 4% YoY organic growth for a ₹200 Cr business, and cut manufacturing costs by 5% using Six Sigma. My edge lies in combining quality discipline, operational understanding and technical insight to deliver compliant, efficient results.

Expertise

Core capabilities

Quality & Compliance

Quality Assurance, Quality Control, QMS, Process Validation (IQ/OQ/PQ), CAPA, OOS/OOT investigations, Stability Studies, APQR, Regulatory Compliance.

Operations & Manufacturing

Manufacturing Operations, Production Planning, Audit Preparedness, Inventory Management, Cost Optimisation, Sustainable Development.

Technical & Commercial

R&D, Technical Support, Product Commercialisation, Process Improvement, Supplier & Vendor Development, Raw Material Sourcing.

Audits & Standards

Governed DNV, customer, global and vendor audits with zero major non-conformities. USFDA, TGA, MHRA exposure. Six Sigma tools — Pareto, RCA, process mapping.

Experience

Career journey

Deputy Manager – R&D · ITW India

Hyderabad · Nov 2019 – Present
  • $77K annual savings across 80 projects via strategic sourcing, vendor development and cost reduction.
  • Orchestrated 4% YoY organic growth for a ₹200 Cr business; led 15+ development & reformulation projects.
  • Turned a critical complaint into a ₹70L revenue opportunity; cut MEP manufacturing costs 5% with Six Sigma.
  • Supported OEM clients including Tata Motors, Mahindra, CEAT, JK Tyres and Apollo Tyres.

Sr. Executive – Quality Control · Strides Pharma

Bengaluru · Jan 2017 – Nov 2019
  • Owned FG-stage OOS/OOT investigations, QMS closure and robust batch disposition.
  • 100% compliance across USFDA, TGA, MHRA, FDA and customer audits as audit SME.

Analyst – Quality Control · Apotex Research

Bengaluru · Mar 2014 – Mar 2016
  • Led technical presentations and process demonstrations for the Canada team with high accuracy.

Officer – Quality Assurance · Micro Labs

Bengaluru · Dec 2010 – Mar 2014
  • 100% timely closure of change controls, deviations, OOS/OOT and complaints via disciplined CAPA.
Credentials

Certifications & education

IMS Internal Auditor
ISO 9001:2015, ISO 14001:2015, ISO 45001:2018 — DNV
IATF 16949:2016 Internal Auditor
Automotive quality management — DNV
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M.Sc — General Chemistry
Kuvempu University, Shivamogga (2009–2012)
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OEM clients served
Bio-coolants, rust-preventing oils & degreasers
Tata Motors
Mahindra
CEAT
JK Tyres
Apollo Tyres

Let's connect

Open to Quality & Operations leadership roles across the Gulf, Asia-Pacific and beyond — ready to relocate.

✉️ shwetha.vallabha21@gmail.com 📞 +91 74111 99682 in LinkedIn 🔒 Job Portal
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