R. SIVASAKTHI
AYANDUR
Summary
QA/QC professional with over 15 of experience in the pharmaceutical industry, with hands-on expertise in GMP, GLP, and regulatory compliance. Proficient in batch record review, deviation and CAPA management, change control, and quality documentation. Experienced in supporting internal and external audits, ensuring product quality, and collaborating with cross-functional teams to maintain compliance across manufacturing and laboratory environments.
Overview
16
16
years of professional experience
Work History
Associate Manager
Himalaya wellness company
Tumakuru
09.2022 - Current
- Implementation and compliance to Current Good Manufacturing Practice norms
- Address the queries during the Audits/Inspection & its compliance
- Review & approval of equipment qualification, area qualification, process validation, hold time study, cleaning validation protocols & reports
- Review, approval, closure and ensure compliance of all Quality Management System activities related to Change control, Deviation, OOS, Incident
- Ensuring for the compliance of environmental monitoring, Calibration and Preventive Maintenance
- The preparation of Monthly & annual reports of QA/QC
- Review and approval of Annual Product Quality Review
- Responsible for review, investigate and response to customer queries and product complaints and initiation of product recall as per the SOP
- Conduct on the job training programmes for continual improvements in shop floor activities
- Responsible for batch record review and product release
- Laboratory operations management in compliance with cGMP and GLP standards
- Conducting and managing stability studies and shelf-life evaluations as per ICH guidelines
- Packing material, Raw material, in-process, and finished product testing using validated methods
- Microbiological testing and environmental monitoring in sterile and non-sterile areas
- Investigation and closure of OOS/OOT results with effective CAPA implementation
- Equipment qualification including IQ, OQ, and PQ for laboratory instruments
- Hands-on experience with LIMS, Empower, Chromeleon, HPLC, UV, and FTIR
- Audit readiness and documentation control for internal and external inspections
- Strong focus on data integrity and compliance with ALCOA+ principles
- Ensuring the In-house and External calibration of QC instruments as per schedule
- Monitoring and management of Reference Standard and Working Standard
- Monitoring and implementation of QC related SOPs
Junior Manager
Syngene International
Bengaluru
12.2017 - 08.2022
- Planning and execution of day-to-day activities in the section
- Work allocation for the sub-ordinates
- Review of analytical reports
- Ensuring the report release within the Turn Around Time
- Involving in release related activities including COA generation
- Involving in QMS investigation (OOS, Laboratory Investigation report)
- Ensuring the laboratory compliance with the cGMP, GLP requirements
- Leading as shift in charge for Non-Chromatography team
- Scheduled work assignments and set priorities for each member of the section
- Monitored processes and procedures, making sure that all met compliance regulations
- Review of SOP, Specifications
- Responsible for reviewing Analytical data of Raw Material, Intermediate, Finish Goods, Stability Study and Working Standard
- Timely release of in-process, intermediate, finished product and raw material
- Quality Management Systems: OOS, CAPA, Deviation, laboratory incident handling and its closure
- Review of entire sampling and analytical activities performing to be in line with SOP
- Responsible for preparation and review of COA for all approved materials as per the project requirement
- Training of new joiners in the section
- Responsible for review of analytical package before submission to AQA
- Ensure availability of contents like standard column before start the analysis
Senior Executive
Micro labs
Bengaluru
08.2013 - 12.2017
- Leading as Raw material- Section head
- Planning and monitoring of raw material analysis in QC
- Entries of sampling and release material in SAP
- Analysis of Raw material, In-process and Finished products as per and In-house specification
- Analysis of stability study samples
- Sampling and Analysis of Raw materials as per Pharmacopoeia and In-house specification
- Calibration of various instruments like High Performance Liquid Chromatography
- Preparation and standardization of volumetric solutions
Officer-quality control
Adcock Ingram Pvt. Limited (Medreich group company)
Bengaluru
07.2012 - 07.2013
- Analysis of Raw material, In-process and Finished products as per Pharmacopoeia and In-house specification
- Analysis of stability study samples
Officer-quality control
Micro labs
Hosur
10.2011 - 06.2012
- Analyze samples using appropriate instrumentation (like HPLC, UV, IR, KF, pH, etc.) while following current Methods & Procedures (SOP's)
- Identify and troubleshooting problems with instrumentation and analytical preparations
- Knowledge in various tests and wet chemistry that pertain to Raw Material analyses (Ex
- Heavy Metals, Residue on Ignition, Specific Gravity, Viscosity, Thin Layer Chromatography, various forms of 'Limit Tests', etc.)
Associate-Quality
Baxter
Chennai
02.2009 - 09.2011
- Issuing of Batch Manufacturing Record and Relevant documents
- Issuing of Product Line clearance during Product change over
- Water analysis
- Analysis of Raw material and packing material as per Pharmacopoeia and In-house specification
Education
Bachelor of Pharmacy -
Annamalai university
Chidambaram08.2008
Skills
- Knowledge of quality systems
- Employee supervision
- Quality control tests
- Data analysis
- Staff training and development
- Chemicals handling
- Performance monitoring
- Team management
Hobbies and Interests
- Watching TV
- Browsing
- Playing Chess
Blood Group
B+ve
Personal Information
- Date of Birth: 15/05/1986
- Marital Status: Married
Timeline
Associate Manager
Himalaya wellness company
09.2022 - Current
Junior Manager
Syngene International
12.2017 - 08.2022
Senior Executive
Micro labs
08.2013 - 12.2017
Officer-quality control
Adcock Ingram Pvt. Limited (Medreich group company)
07.2012 - 07.2013
Officer-quality control
Micro labs
10.2011 - 06.2012
Associate-Quality
Baxter
02.2009 - 09.2011
Bachelor of Pharmacy -
Annamalai university
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