Santhosh Seera
Visakhapatnam,Andhra Pradesh
Summary
Manager leading pharmaceutical quality assurance department , guiding a team members through routine quality reviews and investigations with expertise in QMS activities, TrackWise, and the SAP Quality module. Oversees OOS/OOT, deviation, and complaint investigations while strengthening compliance and preventing critical quality issues in API manufacturing. Builds team performance through disciplined investigation, risk review, and quality system control.
Overview
1
1
Language
1
1
Certification
18
18
years of professional experience
Work History
Manager
Biocon Limited
09.2019 - Current
- Currently, working as a Manager with Biocon Limited, Visakhapatnam from September 2019 to till date.
- Having total of more than 17 years of experience in the field of Quality Assurance in API Pharmaceutical industry.
Deputy Manager-QA
Jubilant Generics Ltd.
06.2016 - 09.2019
- Worked as Deputy Manager-QA from June 2016 to September -2019 at Jubilant Generics Ltd.
- Nanjangud, Mysore, Karnataka, India.
Asst. Manager-QA
Vasudha Pharma Chem Limited
04.2013 - 05.2016
- Worked as Asst. Manager-QA from Apr-2013 to May 2016.
Executive-QA
Acebright (India) pharma private limited.
05.2011 - 03.2013
- Worked as Executive-QA from May-2011 to March-2013 at Acebright (India) Pharma Pvt Ltd.
- Fostered relationships with key stakeholders to align project goals with organizational objectives and drive results.
Executive-Quality Assurance
Shilpa Medicare Limited
11.2008 - 04.2011
- Worked as Executive-Quality Assurance from Nov-2008 to Apr-2011.
Education
Master of Science - Bio chemistry
Andhra University
01.2005
Bachelor of Science - Biochem, Biotech & Microbiology
Andhra University
01.2003
Skills
Handling of QMS activities using Trackwise
Handling of SAP Quality module
OOS/OOT/Deviation/Complaint investigations
Risk assessments
OOT limits using Minitab with graphical representation
GMP compliance
Change control management
CAPA management
Internal audit management
Regulatory inspection readiness
ICH Q7 compliance
ICH Q9 risk management
ICH Q10 pharmaceutical quality system
Annual product quality review
Supplier qualification
Batch record review
Audit response management
Market complaint trending
PQR compilation
Data integrity compliance
EU GMP compliance
Certification
Lean Six Sigma Green Belt
Declaration
I can assure that the above mentioned details are furnished about my experience and education and i will put the efforts in my best for the upliftment of the organization. Thanking You & Yours Sincerely Seera. Santosh
Timeline
Manager
Biocon Limited
09.2019 - Current
Deputy Manager-QA
Jubilant Generics Ltd.
06.2016 - 09.2019
Asst. Manager-QA
Vasudha Pharma Chem Limited
04.2013 - 05.2016
Executive-QA
Acebright (India) pharma private limited.
05.2011 - 03.2013
Executive-Quality Assurance
Shilpa Medicare Limited
11.2008 - 04.2011
Bachelor of Science - Biochem, Biotech & Microbiology
Andhra University
Master of Science - Bio chemistry
Andhra University