BISANI SESHAREDDY
Tirupati
Summary
Currently seeking growth Opportunities in Quality control for an accelerated career path that will enable me to use my strong logical, technical and organization skills towards simultaneous personal and Organizational growth.
Experienced & dynamic quality professional with over 18 + Years experience in Quality Control Department at leading Pharmaceutical Industries.
Overview
13
13
years of professional experience
1
1
Certificate
Work History
Sr. Manager, Head of the Quality Control
Axxelent Pharma Science Private Limited
01.2022 - Current
- Planning and work allocation of Raw material and Packing material, through QLMS- Software to Analyst and review the analytical data
- Actively involved in QMS, LIMS, SAP, EDMS & Instrument qualifications
- Performing GAP analysis as per global procedures
- Hands on experience in complying with documentation and regulatory agencies like USFDA, MHRA, EMA & Health Canada
- Responsible for initiation and closure of QMS and tracking information of day-to-day activities
Junior Manager-Quality Control
Syngene International (A Biocon Co.)
10.2020 - 10.2022
- Handling of QMS like Change control, CAPA, Deviation, OOS through Track wise software (Timely and effective closure)
- Review and issuance of analytical reports to Analyst from Lab ware LIMS, SAP& EDMS
- Verification of Audit trails of related Analytical instruments such as HPLC, GC, UV, IR, Potentiometer & KF Titrator
- Evaluate analytical records for correctness, accuracy traceability and data integrity
- Maintain the RFT more than 95% and report RFT details on monthly basis
- Experience with LIMS Module: Static data management (Master data creation), Lot and sample management and inventory management and Labware ELN
- Experience in SAP Quality Management and integration of SAP with LIMS system
- Planning and Work Allocation of Raw materials and Consumables through LIMS –Software to Analyst
- Ensuring proper management of regulatory audits, internal and external audits
- Taking appropriate decisions whenever necessary without affecting quality and GMP aspects
- Revision of Raw material specifications according to changes in monograph and vendor notification
- Training of Employees on QMS procedures and Good documentation practices
Senior Associate- QA
The Himalaya Drug Company
08.2018 - 10.2020
- Company Overview: Bangalore which produces health care products with Ayurvedic concepts
- It spread across locations in India, the United States, the Middle East, Asia and Europe, while its products are sold in Domestic market (India) as well as 92 countries across the world
- Ensuring the Quality assurance aspects are completed in an appropriate and timely manner including auditing, Compliant review, and document review maintaining for all Contract manufacturing locations
- Review of specifications, SOP's & STP's in HGSM software
- All documents for the adequacy with respect to the principles of ALCOA+
- Ensuring timely completion and subsequent data review of routine QC analytical data review and traceability and data integrity of all the activities being performed
- Conducting regular Audits in Contract testing laboratories (CTL) and contract manufacturing Units
- Based on Audit outcome preparing remediation report and CAPA will get it from CTL's
- Bangalore which produces health care products with Ayurvedic concepts
- It spread across locations in India, the United States, the Middle East, Asia and Europe, while its products are sold in Domestic market (India) as well as 92 countries across the world
Sr Analyst-Quality control
Apotex Research pvt Ltd
04.2017 - 07.2018
- Company Overview: Bangalore which manufactures & distributes generic medications
- It is the largest producer of Generic drugs in Canada
- Worked as Senior Analyst-QC in “Apotex Research pvt
- Ltd
- Working standard Management system
- Issuance Working and reference standards to Analyst from LIMS inventory role
- Good Knowledge of LIMS and coordinate with IT & LIMS support team (Canada) to develop an on-line interfacing of data between LIMS and instrument
- Auditing the electronic and raw data in all stand alone and Empower related instruments to ensure the accuracy
- Performing daily basis internal audit to identify and resolve the GLP and GDP violations
- Calibration of Analytical instruments like HPLC, UV Spectrophotometer, IR, Polarimeter as per calibration procedure
- Bangalore which manufactures & distributes generic medications
- It is the largest producer of Generic drugs in Canada
Executive -Quality control
Strides Shasun Ltd
07.2015 - 04.2017
- Company Overview: Bangalore which is USFDA approved leading provider of pharmaceutical products for regulated & emerging markets globally
- The company also own two dedicated production facilities for the emerging markets at Kenya & India
- Worked as Executive-QC in “Strides Shasun.Ltd.”
- Complex product Analysis like AL Tablets, Vancomycin, LNZ tablets (Assay, Content uniformity, Dissolution & Related substances)
- Ensure Completion of Results entry in LIMS, and submission of reports to AQA
- Participating and coordinating the change control procedures, deviations, investigations of OOS, OOT to aid in determining Root causes
- Bangalore which is USFDA approved leading provider of pharmaceutical products for regulated & emerging markets globally
- The company also own two dedicated production facilities for the emerging markets at Kenya & India
Assistant Trainee-Quality control
Aurobindo Pharma Ltd
06.2012 - 06.2015
- Company Overview: Hyderabad, which manufactures generic & active pharmaceuticals ingredients having approvals from USFDA
- Worked as Assistant Trainee-QC in “Aurobindo Pharma Ltd’’
- Sampling & testing of Raw materials
- Hyderabad, which manufactures generic & active pharmaceuticals ingredients having approvals from USFDA
Education
M.Sc. - Biochemistry
Sri Venkateshwara University
Tirupathi01.2006
B.Sc. - Biochemistry, Chemistry and Microbiology
Dr.A.E.R Degree College
01.2004
Intermediate - Biology, Physics and Chemistry
Sri Chaitanya junior college
01.2001
SSC - undefined
Chaitanya Vidya Mandir High school
01.1999
Skills
- LIMS
- EDMS
- HGSM
- Track wise
- Regulatory Audits
- USFDA
- MHRA
- EMA
- Customer/Partner Audits
- GSK
- Positive attitude
- Teamwork
- Learning new technologies
- Patience
- Commitment
- Communication
- Presentation
Timeline
Sr. Manager, Head of the Quality Control
Axxelent Pharma Science Private Limited
01.2022 - Current
Junior Manager-Quality Control
Syngene International (A Biocon Co.)
10.2020 - 10.2022
Senior Associate- QA
The Himalaya Drug Company
08.2018 - 10.2020
Sr Analyst-Quality control
Apotex Research pvt Ltd
04.2017 - 07.2018
Executive -Quality control
Strides Shasun Ltd
07.2015 - 04.2017
Assistant Trainee-Quality control
Aurobindo Pharma Ltd
06.2012 - 06.2015
B.Sc. - Biochemistry, Chemistry and Microbiology
Dr.A.E.R Degree College
Intermediate - Biology, Physics and Chemistry
Sri Chaitanya junior college
SSC - undefined
Chaitanya Vidya Mandir High school
M.Sc. - Biochemistry
Sri Venkateshwara University
Certification
- NCC- A, B Certificates
- FLP Training certificate
- ERT Certificate
- National Seminar on modern Science
- The safety Mantra
- Fire prevention and firefighting (Government of Karnataka)
Audits
USFDA, MHRA, EMA, Zoetis, Mapp Bio, Keystone, GSK
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