SILAMBARASAN R
Quality Assurance Professional
Mangalore,KA
Summary
Proactive manager with demonstrated leadership abilities, strategic planning expertise and problem-solving acumen. Assists senior managers with accomplishing demanding targets by encouraging staff and coordinating resources. Methodical and well-organized in optimizing coverage to meet operational demands.
Overview
16
16
years of professional experience
5
5
years of post-secondary education
1
1
Certification
4
4
Languages
Work History
Deputy Manager –QA
BIOCON LIMITED
01.2022 - Current
- Responsible for preparation and review of risk assessment pertaining to Product, process and systems.
- Performing Nitrosamine risk assessment, Elemental impurity risk assessment for the products manufactured at the site and communicating the identified risk to the user departments.
- Reviewing the risk at regular intervals and follow up of CAPA derived from the risk assessment reports for effective implementation.
- Performing the various other Risk assessments which are triggered from the recent updates from the regulatory bodies.
- Responsible for handling Customer and Regulatory audits and timely submission of audit compliance report.
- Responsible for the implementation of Cleaning validation software (CLEEN) across all the sites of Biocon.
- Preparation and review of Process, Cleaning validation protocol and reports of APIs & Intermediates
- Preparation of validation master plan for the site and maintaining the schedules
- Identifying the worst-case product in the equipment train, establishing the rinse and Swab limits, investigate quality failure events and resolution of product related deviations during validation
- Performing Dirty equipment hold time (DEHT) studies & Cleaned equipment hold time (CEHT) studies to optimize maximum time that the equipment kept idle in cleaned/dirty state
- Performing campaign cleaning study to optimize the maximum campaign length & cleaning frequency.
- Handling Customer complaints and responsible for investigating the root cause of the complaint to derive the appropriate CAPA
- Handling Internal audits from the Corporate audit team and responsible for timely submission of compliance report.
Quality Assurance
Solara Active Pharma Sciences
11.2019 - 01.2022
- Responsible for handling Customer and Regulatory audits and timely submission of audit compliance report.
- Handling Customer complaints and responsible for investigating the root cause of the complaint to derive the appropriate CAPA.
- Handling Internal audits from the Corporate audit team and responsible for timely submission of compliance report.
Quality Assurance
Nectar life sciences Ltd.
07.2019 - 10.2019
- Responsible for Batch release of both the Intermediates and finished products (Sterile and Non sterile products).
- Frequent walk through to the shop floor and implementing cGMP activity and giving area clearance during product changeover (Sterile and Non sterile plants).
- Handling the change control, Deviations and planned modification. Handling OOS/OOT investigations.
Quality Assurance
Jubilant Generics Ltd.
11.2017 - 06.2019
- Preparation and review of Process, Cleaning validation protocol and reports of APIs & Intermediates. Preparation of validation master plan for the site and maintaining the schedules.
- Handling the change control, Deviations and planned modification. Handling OOS/OOT investigations.
- Preparing Trend analysis for APQR for various products.
- Preparation and review of SOP’S related to QA and manufacturing sections.
- dentifying the worst-case product in the equipment train, establishing the rinse and Swab limits, investigate quality failure events and resolution of product related deviations during validation.
- Performing Dirty equipment hold time (DEHT) studies & Cleaned equipment hold time (CEHT) studies to optimize maximum time that the equipment kept idle in cleaned/dirty state.
Quality Assurance
Orchid Pharma Ltd.
01.2014 - 11.2017
- Responsible for Batch release of both the Intermediates and finished products (Sterile and Non sterile products).
- Frequent walk through to the shop floor and implementing cGMP activity and giving area clearance during product changeover (Sterile and Non sterile plants).
- Handling the change control, Deviations and planned modification. Handling OOS/OOT investigations.
- Preparing Trend analysis for APQR for various products.
- Preparation and review of SOP’S related to QA and manufacturing sections.
- Conducting internal audit as per GMP (self inspection) and follow up of findings.
- Evaluation and approval of new/existing raw material vendor.
Research & Development lab (API)
Orchid Pharma Ltd.
08.2008 - 12.2013
- Worked in drug discovery of novel compounds from grams scale to pilot scale.
- Worked in process R&D for the development of non-sterile and sterile products.
- Having experience in Process implementation and trouble shooting in the bulk drug plant.
- Characterization of novel compounds by analytical techniques and comparison of biological activity.
- Development and optimization of process by employing different synthetic sequences in gram scale.
- Alternate synthetic route set-up to reduce synthesis stages and cost improved process. Improve the yield to get maximum profit and optimization of yield in plant.
- Investigation for out of specification, out of trend, customer complaints and deviation batches with respect to process.
- Performed Material suitability study of raw materials received from new/existing vendors.
- Knowledge in processing HPLC, GC, UV, IR instruments.
- Spectral data interpretation. (NMR, IR, MASS, LCMS).
Education
Master of Science - General Chemistry
Rajah Serfoji College
01.2006 - 01.2008
Bachelor of Science - General Chemistry
Presidency College
01.2003 - 01.2006
Skills
MS OFFICE
DMS
SAP
TRACKWISE
CLEEN SOFTWARE
COMPLIANCE WIRE
Native
Thanjavur, India
Disclaimer
I hereby declare that the information given above is true to the best of my knowledge. I request you to consider my candidature and give me an opportunity to serve in your esteemed organization.
Personal Information
- Father's Name: P. Rajendiran
- Date of Birth: 06/10/85
- Nationality: Indian
- Marital Status: Married
Certification
Computer Literacy Program-NIIT
Timeline
Deputy Manager –QA
BIOCON LIMITED
01.2022 - Current
Quality Assurance
Solara Active Pharma Sciences
11.2019 - 01.2022
Quality Assurance
Nectar life sciences Ltd.
07.2019 - 10.2019
Quality Assurance
Jubilant Generics Ltd.
11.2017 - 06.2019
Quality Assurance
Orchid Pharma Ltd.
01.2014 - 11.2017
Research & Development lab (API)
Orchid Pharma Ltd.
08.2008 - 12.2013
Master of Science - General Chemistry
Rajah Serfoji College
01.2006 - 01.2008
Computer Literacy Program-NIIT
04-2004
Bachelor of Science - General Chemistry
Presidency College
01.2003 - 01.2006