Experience

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  Aurbindo pharma

  Mar 2014 - May 2014

  Internship trainee

  Industrial training which includes glimpses of all the areas of pharmaceutical industry.

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  Biocon

  Jun 2017 - Jan 2018

  Project trainee in quality assurance , qa biologics
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  Biocon

  Mar 2018 - Jul 2021

  Executive quality assurance

  Handled Change Controls from manufacturing, testing, E&M, facility, etc. by complying with GMP requirement. Coordinated with customers, partners and regulatory department for notification and pre approval of changes. Reviewed Equipment qualifications [URS,DQ,IQ,OQ&PQ] by complying with GMP requirementSupported Batch Release ensuring clearance w.r.t temporary changes for quality ®ulatory aspects for batches linked to it.Handled annual Trending of QMS parameters for the evaluation of overall quality impact and CAPAidentification.Handled preparation of APR.Handled internal audits & customer audits. Ø Handled OOS, OOT, Deviations & CAPA. Review of laboratory incidents. Review of finished product & in process test reports. Stability data review & sample pull out scheduling. Review of BMR’s & other relevant documents.Handled market complaints. Preparation of PV and CV protocols. Review and approval of SOP’s.SPOC for management review meetings.Handled trainings for the new joiners.SPOC for QMS aspects from Biocon with manufacturing partner ViatrisCompiling of KPI & quality metrics.SPOC for implementation of track wise software for QMS to be inline with data integrity procedures. Show less

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  Nibrt national institute for bioprocessing research and training

  Jan 2022 - Mar 2022

  Student intern
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  Eurofins biopharma product testing ireland ltd

  Sept 2022 - Jan 2023

  Quality operations lead

  To liaise with the departmental Section and Senior Managers to ensure that resources are available to guarantee the laboratory is in GMP compliance and operating effectively and that there is no impact to the testing teams.To manage the inter-company testing process so all samples are shipped correctly and promptly with the accurate paperwork, and that any follow-up items are prioritized.To provide continuous feedback to all members of their team on all items in relation to customer or organizational requirements/changes. To communicate regularly with their team, the department, and all other appropriate groups to ensure information is transferred effectively throughout the organization. Provide coaching and mentoring to the team as required to improve understanding and compliance in all areas of quality.To handle all relevant client queries and liaise with their team, management, and any other necessary personnel to respond to these queries.To ensure all documentation is authorized and filed accurately in line with company procedures and to write and update SOPs and/or WIs in their area of work.To participate in routine regulatory and client audits and visits, including audit preparation, tours, support queries during the audit, and follow up of actions to closure.To ensure equipment is properly maintained, qualified/calibrated, and, in the event of breakdown, that it is repaired in accordance with company procedures (with reference to timeliness, quality, and cost).To identify any opportunities for improvement of quality and service and work with the team to implement continuous improvement and Lean.To effectively manage and report all quality metrics within the department including exceptions, CAPAs, change controls, SOPs, and EtQ. Ensures all actions are assigned and tracked to ensure compliance with company metrics. To lead the weekly departmental quality meeting. To attend the weekly QA meeting on behalf of the department. Show less

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  Ppd

  Mar 2023 - now

  Compliance specialist

  .To setup PSF and handle the complete project until closure.• To review master batch records.• To review packaging labelling batch records, Drug substance drugproduct batch records.• To review rework and expiry update or relabeling batch records• To review receipts of Incoming In process and finished products.• To carry out pre and post line clearance activities on the floor.• To inspect the P&L activities and review ANSI sampling.• To prepare and review CSPP (Clinical Supplies Project Plan), PSMP(Project specific management plans), Supply chain overview, TEP(Temperature excursion plan) and Quality agreements.• To review study protocols.• To review Quality Events, change controls & CAPA’s.• To carry out product quality dispositions and temperature excursions.• To investigate Supplier Corrective Actions (SCAR’s).• To review client specific SSTA (Study Specific Technical Documents).• To carry out regular site inspections, Internal Audits and Support Clientaudits as specialist on the study.• To prepare QP release documentation, which includes (QP batchconfirmation, Certification & Receipt release)• To research issues, track metrics, and maintain reports anddocumentation related to quality and compliance activities.• To administer quality and compliance processes and ensure appropriateexecution and completion.• To handle projects and process/quality improvement initiatives.• To Communicate with representatives from other departments to ensurequality and timelines are maintained with respect to compliance activities(e.g., client audits, change controls, Quality events, CAPA and/orprocedural documents). Show less