Shyamsundar Swain
Shyamsundar Swain

Pharmaceutical Manufacturing and Compliance Manager

Actively looking · Member since 3 Sep 2026
Message
Location
Pune, India
Desired salary
Unspecified
Work preference
On-site / Full Time
Experience level
Senior

About

Professional summary

I am a pharmaceutical manufacturing and compliance professional with more than 15 years of experience in oral solid dosage (OSD) formulation facilities. My background covers GMP manufacturing, quality compliance, validation, batch documentation, and operational excellence within highly regulated environments.

I have worked in USFDA, EU-GMP, MHRA, TGA, WHO-GMP, ANVISA, NAFDAC, and other regulated-market operations. I am experienced in supporting and facing regulatory audits, managing quality systems, and maintaining compliance with cGMP and USFDA 21 CFR Part 211 requirements.

I lead cross-functional manufacturing teams and have managed teams of more than 40 employees. My leadership experience includes employee training, PLMS coordination, productivity improvement, KPI and OEE implementation, and operational support for external manufacturing sites.

My technical expertise includes deviation management, CAPA, change control, OOS handling, BPR review, IPQA, risk assessment, process validation, cleaning validation, equipment qualification, and SOP preparation. I am also a Six Sigma Green Belt certified professional focused on continuous improvement.

I have international operations experience through a three-month deputation to Luanda, Angola, where I helped establish WHO-GMP manufacturing operations and trained local teams. I am actively seeking Manufacturing Manager, QA Manager, or Validation Manager opportunities in USFDA-regulated facilities, including roles with USA visa sponsorship.

Skills

15 capabilities

Experience

Career history

Associate Manager Shalina Laboratories Pvt. Ltd.

Oversee external manufacturing sites for oral solid dosage products in accordance with WHO-GMP requirements and client expectations. Manage regulatory documentation, compliance activities, audits, and export-market requirements.

Completed a three-month international deputation to Luanda, Angola, to help establish and oversee WHO-GMP manufacturing operations. Trained local team members and supported operational readiness.

Senior Executive – Team Leader Macleods Pharmaceuticals Ltd.

Led a manufacturing operations team of more than 40 employees within the Formulation Division at a USFDA-approved facility. Supported regulated-market manufacturing for the United States, European Union, and Brazil.

Successfully supported USFDA, MHRA, EU-GMP, TGA, and ANVISA audits with zero critical observations. Managed change controls, deviations, CAPAs, and BPR reviews; implemented OEE and KPI initiatives that improved productivity by 18%, and served as PLMS Training Coordinator.

Senior Executive Granules India Limited

Executed oral solid dosage batch manufacturing and related documentation in line with cGMP guidelines at a USFDA and EU-GMP formulation facility. Supported routine manufacturing compliance and documentation activities.

Supported USFDA, WHO-Geneva, MCC South Africa, and NAFDAC audits. Participated in process validation, cleaning validation, and master SOP preparation.

Technical Associate Sandoz Pvt. Ltd.

Worked as a Technical Associate in pharmaceutical manufacturing operations. Contributed to production and compliance activities within a pharmaceutical environment.

Built technical experience supporting manufacturing processes, documentation, and adherence to applicable quality procedures.

Technical Associate Aurobindo Pharma Ltd.

Worked as a Technical Associate in pharmaceutical operations. Supported manufacturing-related activities and routine production processes.

Developed foundational experience in pharmaceutical manufacturing, GMP practices, and production documentation.

Technician USV Limited

Worked as a Technician in a pharmaceutical manufacturing environment. Supported day-to-day production and technical operations.

Gained foundational exposure to pharmaceutical manufacturing processes, equipment operations, and quality-focused work practices.

Education

Learning history

JNTU University, Hyderabad

Bachelor of Pharmacy, Pharmacy

B. Pharmacy, 65%.

EIILM University, Sikkim

Master of Science, Chemistry

M.Sc Chemistry, 67%.

OSBP, Odisha

Diploma in Pharmacy, Pharmacy

D. Pharmacy, 65%.

Utkal University, Odisha

Bachelor of Science, Mathematics

B.Sc Mathematics, 58%.

Alison Institute

Certification, Six Sigma

Six Sigma Green Belt and White Belt certification.

St. John Ambulance

Certification, First Aid Training

First-Aid Trainer Certificate.

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