The document provides a summary of an individual's experience in quality control and analytical roles in the pharmaceutical industry spanning over 11 years. It includes experience managing quality control testing, method development and validation, documentation, audits, and ensuring compliance with regulatory standards. The individual holds an M.Sc. in Chemistry and has worked in quality control laboratories for several major pharmaceutical companies in India and Oman, taking on roles of increasing responsibility including group leader and assistant manager.

1. Quality Control
Analytical R&D
Documention
Investigation &
Problem
solving
SURYA PRAKASH BHYRI
: 00968 -98879638, 94778199
: surya.bhyri@gmail.com
: htts://www.linkedin.com/in/surya-prakash-bhyri-7159b318
: Oman Pharmaceutical Products Co., LLC. Post Box -211, Raysut Industrial Estate, Salalah, Sultanate of Oman
JOB OBJECTIVE
M.Sc. Chemistry with 11+years of rich Analytical Experienced in Pharmaceutical industries managing QC testing for wide verity
of products and formulations. Able to work on own initiative and as part of a team. Proven analytical skills, leadership skills
involving managing, developing and motivating teams to achieve their objectives. Had first-class analytical design and problem
solving skills. Dedicated to maintaining high quality standards.
Seeking Middle Management assignments in field of QC/Analytical R&D in pharmaceutical sector in order to benefit years’ worth
of experience to support your organization.
SUMMARY
M.Sc. Chemistry with 11+years of rich Analytical Experienced in Quality Management,
Analysis, Review, & Documentation
Experience in Quality Control lab relocation and expansion to new facility
Experience in Review of Instrumental /chemical Analysis/ documentation of Tablets, Capsules,
Oral Solution, PFOS & Tropical formulation, and Intermediates, Final Products in API unit.
Interfacing with caliber LIMS software for work allotment, review of results, Data verification, work
sheets taking, and online entry of results.
Handling of Laboratory incidents, OOS, OOT, Change Control Deviation, and
Involving day to day Quality control activity.
Review of Process Validation samples, Submission bathes, Bio-batches analysis, Dissolution profile
summary reports for bio submission..
Extensive experience in Coordinate, contributing during USFDA, MHRA, ANVISA, TGA, MCC,
WHO, BIS, GCC and other Customer Regulatory Audits.
Learning and Implementing GLP's, CGMP & GDP.
Good Experience in Product Stability study Management
Procurement and indenting of monthly requirement of Quality control lab.
Having strong Analytical experience for Method development, validation and method transfer using
HPLC & IC (as per ICH guidelines) for Formulations and API (creams, capsules, tablet, gels, liquids
etc)
Experience in write/Edit/ Review of Quality control lab Standard Operating
Procedures and analytical documents such as Specification, Test Procedure, COAs,
Validation protocol & Validation reports.
Ability to interact and negotiate with external and cross-functional department’s coordination,
Resilience to pressure, risks and complex decision making.
Adept at managing the spectrum of research operations spanning testing, quality control and Deft at
ensuring compliance to quality measures by maintenance of appropriate documentation/ records
CORE COMPETENCIES
Quality Control
Maintaining quality standards and ensuring stringent adherence to quality standards
Identifying gaps & taking corrective action
Undertaking root cause analysis and taking stringent quality measures including preparation of
necessary documents to ensure compliance with above standards & customer requirements

2. ORGANIZATIONAL EXPERIENCE
Oct 2011 – current date: OMAN PHARMACEUTICAL PRODUCTS CO., LLC
Formulation division, Raysut Industrial Estate, Salalah, Sultanate of Oman. USFDA, MCC, ANVISA, MHRA TGA,
GCC, and other regulator approved Formulation Division Manufacturer in wide range of Solid, liquid oral dosage
forms and, tropical’s.
Key Result Areas –Assistant Manager/Group leader
Responsible for managing, coordinating, planning activities of the Stability/Finished product/ Analytical R&D
department and quality documentation to support timely Submitting data/ Release/development. Ensure that
all the activities comply with regulations. This includes developing/coaching personal to ensure the efficient of
the team.
Work allocation, Review of analysis, of Analytical method validation documents, R&D trail batches analysis,
New products process validation analysis planning, Analytical method transfer protocols, reports review
Developing the analytical methods for new products at the facility.
Analytical method validation Protocols, reports preparing and review of analytical method validation reports.
Handling analytical queries from regulatory bodies.
Preparation and Submission of Dissolution profile reports for bio submission.
Handling of Laboratory incidents, Deviation, and Involving day to day Quality control activity
Procurement and indenting of monthly requirement of Quality control lab.
Reviewing Contract giver Methods/ Documents and Participating in Contract giver Teleconferences.
Key achievements:
Leading a group planning day to day Finished product/ Process validation/Stability activities to meet the high
targets. Managed a team of people, assigning those tasks, and motivating them to meet deadlines.
Successful Planning of Analytical R&D team for development/Validation/Method transfer to completion for 25+
wide range of formulation products.
Having vital contributing Part in successfulness of USFDA, ANVISA, MCC, TGA, GCC and regulatory and
costumer related audits.
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Aug 2010 – August 2011: MICRO LABS LIMITED, ML01
Formulation division, Hosur, Tamilnadu. WHO, IDA, Uganda, approved Formulation Division Manufacturer in wide
range of Tablets, Capsules
Key Result Areas –Assistant Manager/Group leader
Responsible to work plan/review/ release for finished product to ensure that all the activities comply with
regulations.
Reviewing the Lab requirements of chemicals, columns, reference standard etc.,
Tacking care and reviewing of Quality control lab ​Compliance/GLP ​activity​
​Reviewing IQ/OQ/PQ-Calibration documents of lab equipment
Key Result Areas
Standardization of analytical processes and procedures between analytical development and quality control
laboratories- Decrease of 38%
Efficiently Planned for Finished product and releases reaching monthly high targets.
Contributed in Successfulness of WHO, Regulatory and other costumer audits.
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Nov 2007 – Aug2010: AUROBINDO PHARMA LIMITED, Unit-III,
Formulation division, situated on Hyderabad, US FDA, MHRA, TGA, WHO approved Formulation Company
Manufacturer Solid dosage forms (Tablets, Capsules etc.,)
Key Result Areas –Senior Executive
To Analyse/Review Bio submission batches, analysis,
To Perform/ Review Analytical Method transfer analysis.
To Perform/Review of calibration of QC equipments, and meantime the GLP activity.
To Analyse/Review of Dissolution profile analysis of Product/ Innovator and preparing of compression
report.

3. Key Result Areas
Successful Analysis completion and contribution in filing of 20+ new products Bio-submission analysis,
dissolution profile comparative analysis with Innovator for different markets.
Successful analysis of Analytical method transfer analysis.
Marinating a GLP activity in QC lab and supporting of audits.
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Dec 2006 – Nov 2007 : HETERO DRUGS LABORRATORIES LIMITED,
Unit-III,EOU Block, situated at Jeedimetla, Hyderabad, US FDA,WHO approved Formulation company
Manufacturer Tablets, Capsules
Key Result Areas –Senior Executive
To Analysis Stability Sample With Compliece. To Prepare the Stability compilation report
To review of stability protocols, To Ensure the Stability analysis within the trend.
To maintain the QC GLP/GDP.
Key Result Areas
Successful Analysis Experience in wide range of molecules stability trend
Good hand of learning and implementation of GLP
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April 2003 – Dec 2006 MYLAN LABORATORY (formally known as Matrix labs Ltd)
Unit-VIII, situated at Pusapatirega,Vizianagaram Dist, US FDA,WHO approved bulk drug company.
Key Result Areas –Senior Chemist
To Analysis and reporting of API Finished product/ Intermediate analysis.
To analysis reaction monitoring /shift monitoring in process activity in Bulk drug QC lab.
To Sampling/analysis of Raw material and coordination with ware house department
Key Result Areas
Good hand of learning Experience of Reaction monitoring analysis in bulk drug
Experience in raw material sampling maintaining QC department responsibility at ware house.
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INSTRUMENTATION KNOWLEDGE:
G.C- Aggilent-7683 Series, Shimadzu-GC2010, 14B
HPLC - Shimadzu-LC20AT&HT, Aggilent-1100, 1200-Series, Waters- Dionex Waters-UPLC
H.S.G.C- Aggilent-6890N, Shimadzu-GC2010 –With AOC, Dissoluition- Electolab
FAMILIAR SOFTWARES:
Chemstation (Agilent technologies) Empower2 (waters), Class VP, Wincrom, L.C.solutions, G.C.solutions.
Chrome lion, Cliber LIMS, TRIMS, QMS.
QUALIFICATIONS:
Master of Science in chemistry,
First grade M.Sc from Vinayaka Missions University, selam. Jan,2011 with 80%
Bachelor of Science in chemistry, Andhra University, Vizag; 1997; Minors: Botany ,Zoology,
Environmental chemistry. With 59%
PERSONAL DETAILS
Nationality : Indian
Father's Name : B. Ramanamurthy
Date of Birth : 05-03-1975
Languages Read & Write : English, Hindi and Telugu