KAMMA DEEPTHI
Summary
9036951999
Current working in stream of Quality Assurance & Compliance at Apotex pharma chem India pvt ltd. Bangalore
OBJECTIVE:
Btech in Chemical Engineering from JNTU University with 10 years of professional experience at pharmaceuticals manufacturing company. Embedded into core values of courage, collaboration, perseverance and passion, strive to achieve patient’s safety, and innovate for patient affordability with high quality and efficiency. Contribute for the continual improvement and success of the organization.
Seeking a challenging position in professional organization and enhance my skills in a competent environment, taking up challenging assignments that offers professional growth while being resourceful and innovative. Contribute for the continual growth and success of the organization.
CAREER OUTLOOK:
B.TECH Chemical Engineering with 10 years of industrial experience in Quality Assurance & Compliance.
Performing and delivering Quality Operations in support of product quality compliance and regulatory workflows.
Handling of QMS activities in applications like TRACKWISE, SAP, QLIKSENSE, GLMS, LIMS etc) to ensure appropriate execution of service deliverables.
Performing trending and analysis on Change Control, Deviation, Investigations, Customer Complaints, environment and water systems, periodic trend assessments and reporting as per applicable procedures.
Performing the periodic review for quality agreements, equipment’s, and make recommendations for amendments to the agreement based on identified needs and issues.
Assessing the impact & risk for the changes in any of the approved validated process/procedures/equipment’s/facilities through change control management system in track wise.
Experience in risk identification, risk control and risk reduction through risk management tools.
Escalating service related GxP and non-GxP issues and ensure timely investigation and compliance with local and global operating procedures.
Striving to increase process capability and reduce product variability and defects by enhancing product and process design by Quality by design (QBD).
Handling of Computer system validations, equipment qualification, HVAC Validations.
Experience in review and approval of URS, FDS, DQ, FAT, SAT, IQ, OQ, PQ activities as per qualification requirements
Assessing ER/ES compliance with 21 CFR part 11 requirements.
Performing periodic review of computerized systems, equipments by assessing overall effectiveness and state of control on validation.
Experience in conducting Temperature mapping studies at pharmaceutical industries.
Performing Self inspection and Internal Audits, un-announced real time checks.
Supporting regulatory inspections, managing and developing regulatory authority communications globally, evaluating current trends and reporting on risks to current organization.
Overview
10
10
years of professional experience
Work History
Senior Quality Assurance Officer
Apotex Pharmachem India Private Limited
Bangalore, India
08.2014 - Current
Quality Assurance Officer
Adcock Ingram, Medreich Pharma
Bangalore
10.2012 - 08.2014
engineer of Technical services
Vasant Chemicals Pvt.Ltd
Hyderabad
08.2011 - 09.2012
Education
B. TECH - Chemical Engineering
BVRIT College (JNTU)
Intermediate - undefined
Narayana junior college
SSC - undefined
Montessori High School
Skills
SAP, TRACKWISE, LIMS, TRAINING MASTER FILE, QMS, CHEMCAD, AUTOCAD, MATLAB Computer literacy includes advanced level computer skills in MS Office, Word, Excel, and PowerPointPERSONAL DETAILS:Nationality : IndianD/O/B : 22/05/1990Marital Status : MarriedEnglish, Hindi, Telugu, KannadaHobbies : Playing Shuttle, Throw ball, Gardening
Timeline
Senior Quality Assurance Officer
Apotex Pharmachem India Private Limited
08.2014 - Current
Quality Assurance Officer
Adcock Ingram, Medreich Pharma
10.2012 - 08.2014
engineer of Technical services
Vasant Chemicals Pvt.Ltd
08.2011 - 09.2012
B. TECH - Chemical Engineering
BVRIT College (JNTU)
Intermediate - undefined
Narayana junior college
SSC - undefined
Montessori High School