Quality Assurance Control

Sankar Ramu

Masters of Science

Maple shade, Newjersey-08052

E-mail: ad8swp@r.postjobfree.com, Phone: +1-732-***-****

PROFESSIONAL SUMMARY:

Having Fifteen years of experience in Analytical R&D and Quality Control & Quality Assurance department in the pharmaceutical industry. Able to lead large teams and meet company deadlines while still producing high-quality, safe, and consistent medications. Fully capable of using all major laboratory technologies efficiently to improve processes and output. Dedicated leader with the belief that teams perform best with regular, honest feedback and an open dialogue about performance. Detail oriented and can perform technical duties following standard operating procedures and general laboratory safety rules. In my years of Experience, I have been working with GLP, cGMP, Safety, as per Guidelines and with discipline and faced many audits like WHO, USFDA, MHRA & other customer audits.

SKILLS:

●Method Validation, Development and Method Transfer knowledge.

●Experience working with a wide range of laboratory equipment.

●Hands on experience on handling: High Performance liquid chromatography (HPLC) Ultra performance liquid chromatography (UPLC), Gas chromatography (GC) with Empower and Chromeleon Software

●Detection techniques: UV, Visible spectrophotometry and Atomic absorption Spectroscopy.

●Particle size analyzer (Malvern zetasizer)

●KF with Tiamo Software (Metrohm)

●Handling of Dissolution Apparatus (Electro Lab, and Lab India)

●Other analytical techniques: FT-IR, Viscometer, Thin-layer Chromatography.

●Activity of LIMS,QUMAS,SAP & Master Control Software.

●Troubleshooting and problem-solving skills of All analytical Instruments.

WORK EXPERIENCE:

Apta Pharma Inc, Pennsauken Township, New Jersey: Senior Chemist/Reviewer in Quality Control / Research and development from December- 2023 till date.

●Responsible to perform method development and Method validation of methods in support of manufacturing including in-line and finished product release testing using various analytical techniques.

●Chemical analysis of finished drug product, the raw material (API-Active Pharmaceutical Ingredient / Excipient), In -process samples and stability study sample analysis.

●Preparation and review of method transfer and validation as per current compendial changes and ICH guidelines.

●Responsible for reviewing the data and records for preventative maintenance and calibration records of instruments like HPLC, Dissolution apparatus, Analytical Balance and pH meter.

●Responsible for Author reports, protocols, test methods, and other documentation all as required for compliance.

●Initiate, review and Evaluate for root cause Investigation like, out of specifications (OOS), out of trend (OOT), deviations Market complaints etc.

●Review and approval of Stability data reports, Analytical Test Methods, qualification/validation protocols from method transfer.

●Responsible for handling Incidents and repeat analysis as per respective SOP.

Novitium Pharma LLC, Chennai, India: Senior QA Associate from Sep-2022 to Nov- 2023

●Responsible for reviewing raw data generated by the laboratory to ensure compliance to good documentation practices.

●Initiate and evaluate the root cause investigation samples (OOS, OOT and Aberrant results ).

●Review, Qualification and Approval of SOP’s, laboratory notebooks, study protocols, reports, analytical methods, and instruments (DQ/IQ/OQ/PQ.).

●Initiate and completion of change control and deviation related to analytical laboratory

●Responsible for reviewing LIMS data and Master Control data generated during the daily laboratory activities performed by the analysts to ensure compliance.

●Responsible for reviewing of stability data, preparation and reviewing of stability compilation data.

●Responsible for the analysis of stability samples as the stability schedule planner.

●Responsible for Analytical Method validation, Method verification, Method Equivalency studies and Method transfers for drug products as per ICH and pharmacopeial requirements.

●Preparation of Method validation report and Method Equivalency reports.

●Playing an important role in GMP lab quality representative in laboratory management to ensure all activities are performed as per standard operating systems and guidelines requirement.

Teva Pharmaceutical Limited-(Actavis Pharma) Chennai, India: Analytical Quality Assurance (QMS& Compliance) Mar 2015 to Sep 2022

●Manage and schedule for day to day activities related of the QC Laboratory group members.

●Review all laboratory related documents to ensure that Quality Control Laboratory: finished products, bulk, raw material stability, and Microbiology meet and GMP requirements prior to release.

●Calibration and Maintenance of analytical instruments (HPLC, GC, Dissolution, FTIR& KF etc.).

●Initiate, review and Evaluate for root cause Investigation like, out of specifications (OOS), out of trend(OOT), deviations Market complains etc. and derive appropriate Corrective and preventive actions (CAPA).

●Participating and Collaborate with cross-functional teams to resolve complex method development, method validation and method Transfer challenges.

●Strong knowledge about analytical testing including analytical instruments like HPLC, UPLC, GC, KF, spectroscopy, and dissolution with the ability to problem solves complex analytical issues.

●Preparation, revise and review SOP’s, analytical protocols, analysis reports, specifications, and controlled forms.

●Good exposure in GMP compliant in analytical lab, with a good knowledge of USFAD & EU quality regulations and GMP/GDP Guidelines.

●Demonstrate expertise and strong knowledge in chemistry and assist in product and process troubleshooting.

●Active person in Major Regulatory audits, internal audits, client inspections of the site which includes the satisfactory execution, follow up, and closure. (MHRA, USFDA, TGA).

●Support oversight of cGMP sample handling, testing, QC release and stability data analyses and method data trending, out of specification investigations, and Certificates of Analysis creation.

●Preparation of laboratory process improvement initiatives such as lean lab principles, implementation of electronic laboratory notebooks and ERP and SAP systems.

●Working with across functions with Participate in method development, verification and validation testing and studies with supervision.

●Sound Knowledge and Continues monitoring of Data integrity (ALCOA+) and compliance as per regulatory norms (FDA- 21 CFR regulations) and ICH guidelines.

●Active person in team discussions and contributes with recommendations to help improve procedures.

Strides Arco Lab Ltd, Bangalore, India: Senior Chemist from July-2014 to Feb 2015

●Responsible performing of finished product and Stability section to performing all analytical activities of drug products

●Responsible for reporting the Incidents results in a timely manner to facilitate the investigations.

●Responsible for reviewing and maintaining of working standards, chemical standards and Non-routine activities in Quality Control department.

●Responsible for preparation of protocols for the Qualification of Instruments.

●Experience of working in a FDA regulated environment.

Orchid Pharmaceuticals Limited, Chennai, India: Chemist in Quality Control department from Nov 2012 to Jul 2014.

●Responsible for the Analysis of Solid Oral dosage forms (Tablets and Capsule Pellets) as per STP's and Protocols for In process, Raw material, Finished and Stability samples.

●Responsible for Calibrations of instruments like Analytical Balance, pH meter and Dissolution apparatus .

●Responsible for Raw material sampling.

●Responsible for carrying out the allotted samples of In Process, Finished Products and timely Completion of documentation.

●Ensuring proper calibrations of Instruments and the data integrity.

●Responsible for maintaining the allotted samples and standards at appropriate storage conditions till the analysis completion and disposal.

●Responsible for documenting and reported results as per established SOP/STP.

●Responsible for maintaining proper documentation of laboratory data, complete testing, data evaluation and timely reporting.

Shasun Pharmaceuticals Limited,Pondicherry, India: Chemist in Quality Control department from Nov 2012 to Jul 2014.

Performed routine testing of Physical parameters, Assay and Dissolution in Finished product and stability studies.

Daily calibration of analytical instruments. (Balance, pH, KF titrator)

Maintaining of all Stability chambers records and responsible for pull-out and loading of stability samples.

ACADEMIC RECORD:

Master degree ( Biochemistry with Bioinformatics ) 2007-2009.

● From University Of Madras, Chennai, India.

Bachelor’s degree (Biochemistry ) 2004-2007.

● From St.Joseph’s College of Arts & Science,Tamilnadu, India.

Declaration:

I certify the above-mentioned information is true to the best of my knowledge and nothing has been concealed. I have been always sincere and hardworking and would always work honestly for growth and development of the organization.

( Sankar Ramu)

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