Profile Summary

Persuasive & influential professional with expertise Pharmaceutical manufacturing industries, strong in Team Management, Analytical Method Validations and Technology Transfer; offering regulatory exposure in USFDA, TGA, MHRA & ANVISA Consistently achieved business unit objectives and goals, ensured safe and efficient operations of the laboratory & implementing operational SOPs with emphasis on safe, reliable and system performance and efficient operation of the plants Led execution of Quality activities like transfers of analytical methods, validation and their regulatory submissions, evaluation of pharmacopoeia method against in-house developed methods & routine release analysis in Quality Control Laboratory Skilled in validating the products in terms of Critical quality attributes and Critical quality parameters and continuously monitoring the manufactured products for its continuous improvement Excels in managing strategic and operational performance of Quality management systems such as CAPA (Corrective & Preventive Action), Discrepancy Management (Incidents), Investigations, Deviations and Phase two investigation of OOS (Out of Specification) as per regulatory guidelines

Followed risk management approach in QMS policies, strategies, procedures and practices; devised an appropriate mechanism to detect risk to products and took expeditious for its containment Demonstrated organizational and time management skills, appropriate and timely decision-making, including the ability to prioritize tasks in response to emergency situations

Core Competencies

Quality Control & Quality Assurance

Computer System Validations

Internal External & Vendor Audits

Analytical Method Development, Validation

& Transfer

Regulatory Adherence & Compliance

Management

Process Robustness & Development

Stability Studies

Total Quality Management

Project Planning & Execution

Escalations & Technical Resolution

Deviation & Change Control

Training & Team Development

Career Timeline

Academic Details & Certification

M. Sc. in Bio-Chemistry, from Acharya Nagarjuna University College, Nagarjuna University B. Sc. in Botany, Zoology & Chemistry, from PBN College, Nagarjuna University, Nidubrolu Certificate course in Computer Basics (MS Word, MS Excel) Certificate course in Computer System Validation

SAMI SHAIK - Senior Pharmaceutical Quality Professional Results-driven professional with over 17 years of experience and proficient in overcoming complex problems within fast paced high pressure & consent decree environments and understand the importance of regulatory & compliance, targeting next level opportunities in Quality Control, Quality Assurance, Research &Development with an organization of high repute across Pharmaceutical & Health Care industry for mutual growth

adtvx9@r.postjobfree.com +91-738*-**-****

Spar Pharma LLP

Vijayasri Organics

Pvt. Ltd.

Shilpa

Medicare Ltd.

Dr. Reddy’s

Laboratories Ltd.

Neuland Laboratories Ltd.

Jupiter Bioscience Ltd.

2005 - 09 2009 - 11 2011 - 12 2012 - 19 2019 - 22 Since 2022 Work Experience

Since Oct’22 with Spar Pharma LLP (Unit of Vijayasri Organics Pvt. Ltd) Visakhapatnam as Head of the Department-Quality Control May’19 – Sep’22 with Vijayasri Organics Pvt. Ltd., Visakhapatnam as Sr. Manager – Quality Control Key Result Areas Across Career:

Currently managing team size of more than 20 members and setting up plants for new API facilities Facilitating seamless technology transfer in coordination with internal departments like Purchase, Production, Regulatory Affairs, Quality Assurance, Project Management and Engineering

Reviewing documentation evidence covering identification of instruments, frequency of re-calibration, calibration status Working with Operations Department and Technical Services for effective operational control, organizing test runs of new feed, specific product specification requirements

Interfacing with customers, surveyors for complaints and organizing retesting after product transfers and clarification of test results, test methods used and testing requirements

Organizing and managing activities of the Incoming Feed, In-process and Finished Products Section to the specified requirements in accordance with the quality plan and documented procedures Training employees as Chemists, Analysts, Technicians, for process engineer’s familiarization in the laboratory Identifying, calibrating and adjusting all inspection, measuring and testing equipment and devices that can affect product quality at prescribed intervals or prior to use

Supervising Pharma QC Process development, regulatory, project management warehouse teams to deliver the analytical needs of commercial and new molecule validations successfully and timely Providing analytical support to R&D and pilot scale laboratories for analytics Preparing MIS for QC Laboratory and presenting to the management Monitoring the Quality Control Department activities towards ensuring the timely service to all internal customers Generating monthly reports which include No. of Incidents & OOS, HPLC&GC Utilization Time, Budget Details pertaining to the lab Supporting USFDA audits for preparation of departmental sops, records Spearheading day-to-day planning for analysis of raw materials, in- process samples, finished products, and stability samples Reviewing Analytical Reports & improving quality standards in the organization by implementation of new processes Maintaining Instrument Logbooks and instrument calibration records, HPLC & GC systems Preparing IQ, OQ and PQ protocols for Q.C related instruments & non-conformities, Out Of Specification (OOS) reports Introducing and enforcing quality systems / procedures to ensure strict adherence to specified quality norms Implementing preventive, predictive & corrective maintenance practices to maximize operational availability of machines Providing key scientific and technical support for issues related with Process/Analytical/ Packaging at the facility Previous Experience

Aug’12 – Apr’19 with Shilpa Medicare Ltd., Visakhapatnam as Dy. Manager – Analytical Research & Development Significant Highlights:

Played a key role in developing HPLC method for resolving recovery issue in Ibrutinib Premix and also played a key role in audit conducted by UDFDA

Acknowledged for drafting Analytical Research & Development operational related (Instrumental)SOP’s Played a key role in affectively utilize the minimal resources and validating various method validations by LC-MS Dec’11 – Aug’12 with Dr. Reddy’s Laboratories Ltd., Hyderabad as Sr. Executive – QC Department Mar’09 – Dec’11 with Neuland Laboratories Ltd., Hyderabad as Officer - QC Feb’05 – Mar’09 with Jupiter Biosciences Ltd., Hyderabad as Chemist - QC Personal Details

Address: Sk. Sami, S/O- Sk. Md. Ruholla, D.No. 3-134/17, Flat No. 303, Nakshitha Enclave, Near MOM’s Hospital, Prasanthi Nagar, Aganampudi-530046, Visakhapatnam, Andhra Pradesh (India) Languages Known: Telugu, Hindi & English

Date of Birth: 5th March 1980