Quality Assurance Regulatory Affairs

Sesha Phanindra Santikari

Mississauga, ON, L*G *E1 437-***-**** ***********@*****.***

Summary:

Pharmaceutical professional with over 16 years of diverse experience in industrial, regulatory, and academic settings. Proven expertise in quality assurance, compliance with Good Manufacturing Practices (GMP), and analytical method validation. Highly detail-oriented with a strong ability to work collaboratively in fast-paced environments. Committed to maintaining high safety and quality standards. Educational qualifications:

M. Pharmacy (2006-2008), Pharmaceutical Analysis from VEL'S College of Pharmacy, (Affiliated to Dr MGR Medical University), Chennai, INDIA.

B. Pharmacy (2002-2006), from Raghavendra Institute of Pharmaceutical Education and Research, (Affiliated to J.N.T.University), Hyderabad, INDIA.

Technical Skills

Manufacturing & Quality Control: Good Manufacturing Practices (GMP), Good Laboratory Practices

(GLP), quality inspections, documentation of procedures, SOP adherence.

Analytical Equipment Proficiency: HPLC, spectrophotometers, dissolution apparatus, and more.

Software Proficiency: Microsoft Office Suite, LIMS, OpenLab, Empower.

Regulatory Knowledge: ICH Guidelines, FDA compliance, method validation protocols. Additional Skills

Excellent interpersonal and communication skills, both oral and written.

Repetitive Task Management: Efficiently perform repetitive tasks while ensuring quality and accuracy.

GMP Compliance: Knowledge and experience in working within Good Manufacturing Practices

(GMP) environments.

Industry Expertise: Familiarity with pharmaceutical manufacturing industry standards and regulations.

Fast-Paced Environment Adaptability: Proven ability to thrive in fast-paced settings, including assembly line operations.

Weekend Availability: Flexibility to work weekends as required by operational needs.

Team Collaboration: Strong team player with a positive attitude, focused on quality assurance and attention to detail.

Physical Capability: Able to lift weights up to 25 kgs. WORK EXPERIENCE

Regulatory Affairs, Assistant Manager

Velzen Pharma Private Limited, Hyderabad, India

Mar 2022 - Aug 2024

Preparation and submission of Original ANDAs to the USFDA and ANDS to Health Canada ensuring compliance with eCTD formatting and regulatory requirements.

Conducted quality checks on documentation and ensured adherence to GMP, ICH, GCP standards during the submission process

Review and signing of CMC documents from plant including but not limited to SOPs, Specifications, STPs, BMRs, BPRs, Process validation Protocols & reports, Stability Reports, ICH Q3D, Q3C RA reports, Alcohol dose dumping reports etc.

Prepared departmental SOPs adhering to GMP & Quality standards. Regulatory Affairs & Quality Assurance (Freelancer) MLV Pharma LLC, USA

Jan 2020 - Jan 2022

Prepared and submitted regulatory dossiers in line with Health Canada & USFDA guidelines.

Review of various GMP documents before Regulatory submissions Trainee (Production)

Sumac Pharma Pvt Ltd.

May 2005- June 2005

Assisted superiors in Production department during various equipment filling and packaging operations. Research & Academics

Surabhi Dayakar Rao College of Pharmacy, Telangana, India Mar 2008 - Jan 2022

Developed and validated chromatographic methods, ensuring compliance with regulatory standards for pharmaceutical analysis.

Process validation of various drugs

Guided students in research projects, emphasizing quality control and thorough documentation practices.

Organized workshops focused on regulatory affairs and quality assurance in pharmaceutical settings.

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