Preeta Caroline
Quality Assurance Specialist
Bangalore
Summary
Results-oriented Quality Assurance Professional with 7 years of experience in ensuring the highest standards of product and process quality. Proven track record of designing and implementing effective quality control systems, conducting comprehensive audits, and driving continuous improvement initiatives. Adept at collaborating with cross-functional teams to identify and resolve quality issues, optimize processes, and enhance product reliability. Exceptional analytical skills, attention to detail, and a commitment to maintaining regulatory compliance. Seeking to leverage my expertise in quality assurance to contribute to the success and growth of the company.
Overview
7
7
years of professional experience
6
6
years of post-secondary education
5
5
Languages
Work History
Senior Document Coordinator (Permanent - Remote)
Alexion AstraZeneca Rare Diseases (Payroll Of Atidan Technologies Pvt. Ltd.)
12.2021 - Current
- Performing and facilitating document management process to ensure timely revision, review, approval, and effectiveness of controlled GxP documents.
- Documents in scope include both electronic and paper versions using Experience and knowledge of global Quality Management Systems (QMS), Experience with IT systems used in industry, including TrackWise, Veeva Vault, Learning Management (SumTotal preferred) and Microsoft Office Applications
- Have worked as lead investigator for over 6 deviations on TrackWise in 2023 and have implemented effective CAPAs.
- Have been trained as certified investigator for deviations in Astrazeneca's QMS system.
- Reduced miscommunication errors by standardizing templates for internal and external correspondence.
- Updated procedures to add clarity and ensure compliance with regulatory requirements.
- Ensured accuracy of all documents by diligently proofreading, editing, and reviewing content before final submission.
- Enhanced collaboration between departments through effective communication and timely document distribution.
- Have worked on and assisted colleagues on ensuring that created Change Controls are implemented and closed out on time.
- Fostering collaboration with training department to synchronize content and timeline inputs.
- Providing valuable support during inspections and audits by conducting systematic queries of both systems and documents.
- Contributing to initiatives aimed at archiving retired and decommissioned documents and records.
- Assisting in execution of routine periodic review requirements.
- Trained over 5 new joiners on procedures and helped them get inducted into their job roles.
Senior Executive - Quality Assurance (Permanent)
TrialGuna Pvt.Ltd.
02.2020 - 09.2021
- Planned resources and conducted over 35 audits (site audits, vendor audits, in house audits, system audits etc.) to identify deviations from applicable guidelines, regulations and Protocol (wherever applicable).
- Have worked as QA for sponsor company during COVID vaccine trial for both adults and children.
- Have overseen over 50 healthy volunteer studies as QA.
- Spearheaded process improvements that resulted in higher efficiency levels without compromising product quality or safety standards.
- Contributed to cost savings initiatives by identifying inefficiencies in production processes and recommending solutions for improvement.
- Mentored junior Quality Assurance team members, fostering learning environment that promoted skill development and knowledge sharing among colleagues.
- Sensitized individuals and teams on deviations and process followed thereof to influence corrective actions to be carried out.
- Collated and analyzed over 60 audit reports to identify systemic root causes of defects and partner with relevant stakeholders (including head of monitoring, project management, project manager, HR and training) for enabling process improvements leading to deviations minimization/amelioration.
- Developed and executed over 23 QA SOPs, in line with global best practices, related to QA activities, such that resources including time and costs are optimized
- Coordinated and developed over 40 SOPs, in line with global best practices, related to activities in study monitoring, project management etc
- Ensured effective training to all colleagues, differentially as per QA norms/SOPs to ensure deep understanding, internalization and adherence of SOPs by colleagues
- Reviewed documents (e.g Protocol, informed consent document, case report forms etc.) created in-house or received from sponsor for their compliance to applicable guidelines, regulations and protocol wherever applicable and provide feedback
- Reviewed over 20 study files for QA green signal for first-time release of study drugs to site or site initiation
- Coordinated over 50 external audits and inspections.
Senior Executive - Quality Assurance (Permanent)
Syngene International Limited
07.2017 - 01.2020
- Responsible for QMS (Quality Management System) of departments related to Bioanalytical Research Laboratory - viz. GLP and relevant BA / BE guidelines; Data Management and Biostatistics and other support departments as per requirement.
- Have been part of over 7 regulatory audits like US FDA, Thai FDA, MHRA and EMEA over a span of 2 years
- Prepared and revised of over 20 SOPs' relevant to their area; review of SOPs' from relevant departments; issue of SOPs', forms and log books to relevant departments; retrieval of obsolete SOPs'; control of master (original) SOPs' - current as well as obsolete SOPs'
- Taken over 17 relevant change controls, review of change control taken by departments, follow up of same for closure.
- Controlling and maintaining records in QA department
- Reviewed over 60 qualification and validation documents
- Planned (including preparation of relevant audit related documents, review of documents) and performed relevant audits: study-based audits (including site audits), quality system audits, process audits, vendor audits
- Conducted over 50 audits for following vendors: Biomedical waste management, couriers, third party archival, calibration agencies, laboratory reagent suppliers; software and instrument vendors
- Conducted over 7 system audits for the following departments: Bioanalytical Research Laboratory, Human Pharmacology Unit, Data Management and Biostatistics, Regulatory Affairs, Maintenance, IT
- Analyzed root-cause for over 15 non-compliance/deviations; analyzed trends observed (if any) and advised on resolving issues
- Communicated lessons learnt to fellow QA personnel and apply best practices across departments.
- Served as subject matter expert for Quality Assurance-related topics during internal and external presentations, positioning the company as an industry leader in product quality and customer satisfaction.
Education
Master of Pharmacy - Pharmacology
Krupanidhi College of Pharmacy
Bangalore 08.2015 - 05.2017
Bachelor of Pharmacy -
The Oxford College of Pharmacy
Bangalore 10.2010 - 12.2014
Skills
MS Officeundefined
Work Achievements
- Obtained certification for Technical Writing Principles from Pathwise on 30-Aug-2023.
- Assisted during migration of document management system from Alexion Vault Quality systems to AstraZeneca ECMS to ensure compliance.
- Certified lead investigator for deviations managed within ECMS.
- Trained new joiners about system and procedures.
- Participated in 7 COVID-19 trials since April 2020 including COVID-19 vaccine trial as Quality Assurance Personnel.
- Participated in several personal care studies as Quality Assurance personnel.
- Participated in Clinical Research course conducted by the organization as a trainer and coordinator.
- Help build the quality management system and was an active part of getting the organization ISO 9001 certification.
- Received Certificate of Appreciation 'In recognition of team dedication and contribution to the company's success and many successful sponsor audits and confirmed new business' in December 2017.
- Completed Lean and Six sigma white belt certification.
- Completed 'Train the Trainer on EQMS- Trackwise 9.1' in January 2019.
- Participated in the 'Workshop on ICH GCP' in August 2019.
- Completed Two days In-House training on 'Technical Writing Skills' in September 2019.
Training
- One month industrial training at Geltec Pharma, Attibele in 2014.
- Two months Pharmacy training at St. Johns Medical College in 2014.
- Senior Executive -Quality Assurance trainee at Syngene International Limited from Apr 2017 to Jul 2017
Timeline
Senior Document Coordinator (Permanent - Remote)
Alexion AstraZeneca Rare Diseases (Payroll Of Atidan Technologies Pvt. Ltd.)
12.2021 - Current
Senior Executive - Quality Assurance (Permanent)
TrialGuna Pvt.Ltd.
02.2020 - 09.2021
Senior Executive - Quality Assurance (Permanent)
Syngene International Limited
07.2017 - 01.2020
Master of Pharmacy - Pharmacology
Krupanidhi College of Pharmacy
08.2015 - 05.2017
Bachelor of Pharmacy -
The Oxford College of Pharmacy
10.2010 - 12.2014
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