Quality Assurance

SHANTHIMATHY THIRUCHELVAM

** ****** ****** *****, *******, Ontario, L3R 8V1

**********@*****.***

905-***-**** Cell: 647-***-****

POSITION: Quality Assurance Associate

SUMMARY

Extensive experience in Quality Operations within pharmaceutical and GMP environment.

Strong knowledge and solid understanding of US FDA and HPFBI GMPs and ICH guidelines.

Sound knowledge of storage and distribution of pharmaceutical and regulated products.

Quality Systems experience includes change control processing, non-conformance investigations, root cause analysis and CAPA.

Provided on-going quality oversight and direct support of quality systems in the areas of manufacturing, packaging, warehouse, QA, QC and material management.

Innovative and results driven. Very quick learner of different systems and operations.

Excellent organizational and planning skills. Strong documentation and reporting skills. Uses strategic thinking and creative problem solving skills. Successfully handle multiple projects and tight timelines.

High performing individual; makes suggestions to improve the business and works best as lean. Demonstrated ability to react quickly in urgent situations.

Detail oriented and dedicated.

Works well in a fast-paced team environment and individually.

Strong interpersonal skills at all levels of the organization and in a variety of functions; able to influence and motivate others to quickly achieve results.

Performed AQPIC functions.

Experience in all aspects of Laboratory Information Management System (LIMS) and other QMS systems such as Track Wise, SAP, and Oracle. Well versed in Microsoft office suit (Word, Excel, PowerPoint, & Outlook). EMPLOYMENT EXPERIENCE

Quality Assurance Specialist/ Manager 2013 – Present Intellipharmaceutics Corp.: Toronto, Ontario

Serve as a point of contact for quality assurance and regulatory affairs queries.

Maintain documentation system and archiving of technical file documentation.

Conduct timely review and approval of master production documents and executed batch documents.

Review and approve protocols and ancillary documents prior to finished product release ( i.e. change controls (CC), non- conformance reports (NCR), laboratory investigation reports (LIR), standard operating procedures (SOP), test methods etc.)

Perform timely release of in-coming materials (APIs & Excipients), in-process products, bulk and finished products.

Review and approve laboratory investigation reports (LIR); raw material, in-process, bulk, finished product and stability test specifications; test methods and method validation reports.

Perform QA approval of change controls. Oversee processing of change controls to ensure timely execution and closure.

Conduct thorough non-conformance investigation and assign CAPA.

Review Annual Product Review Reports and perform trending.

Oversee sampling process for in-process, bulk, finished products, and stability and retention samples in production area.

Conduct complaint investigations in timely manner.

Participate in inspection readiness activities as required for compliances and regulatory/third party inspections.

Conduct cGMP training program for new and current employees. Support the overall employee training as required for operational and quality requirements.

Ensure the preventive maintenance; environmental monitoring and pest control activities are taken place as scheduled. Review and approve the relevant reports.

Monitor temperature and humidity monitoring system and ensure it is fully functional at all times.

Perform audits of suppliers, vendor, and contract testing laboratories areas to ensure compliance with cGMP standards, site requirements and policies.

Provide consultation to production, quality control laboratory, materials management and other GMP functional area to ensure compliance to cGMPs, SOPs and applicable policies.

Actively involves in all aspects of handling controlled substances and their movement.

Oversee warehouse/product status.

SHANTHIMATHY THIRUCHELVAM

25 George Martin Drive, Markham, Ontario, L3R 8V1

**********@*****.***

905-***-**** Cell: 647-***-****

Project Leader, Global Quality (Contract) 2013

Apotex Inc.: Toronto, Ontario

Developed and executed quality agreements with external suppliers.

Acted as the primary contact for all product quality issues that held up the final disposition of the product manufactured by third party contract manufacturer.

Ensured external drug product supplier related investigations are conducted in a timely and efficient manner leading to root cause elucidation and correction. Ensured that established procedures were followed for all investigations and preventive actions were implemented. Conducted impact analysis of proposed corrective & preventive actions. Discussed findings with impacted departments such as QA, RA, Validation, Production etc.

Served as a technical resource; reviewed all investigation reports, associated change control, validation protocol/reports, and master documentation for the North American market place.

Reviewed/approved method and process validation protocols and reports. Supervisor, Quality Control Laboratory 2010– 2013

Taro Pharmaceuticals Inc.: Toronto, Ontario

Scheduled and assigned work efficiently to utilize resources while meeting customer demands. Accommodated operational priorities. Ensured the release of in-process material testing to expedite the packaging step.

Ensured that all operations were in compliance with cGMP regulations, company policies, safety standards and departmental procedures.

Conducted timely documentation review of raw data and log books to ensure compliance to applicable standard procedures and specifications for products such as creams, ointments, gels, nasal sprays, solutions, liquids, capsules, coated and uncoated tablets.

Ensured all documents were properly controlled, maintained, and archived.

Performed QC Approval of Standard Operating Documents that detailed testing, maintenance and quality procedures.

Reviewed and approved change controls in a timely manner.

Communicated effectively with other departments such as production, sampling, packaging, logistic etc. in order to fulfill business needs and ensure product quality.

Reviewed current systems and procedures such as SOPs, methods, testing procedures and specifications of internal and foreign sites and suggested improvements and initiated change controls to implement changes.

Developed expertise and provided guidance and leadership on quality issues on a routine basis.

Assisted with the re-sampling and re-testing process according to the NCR and CAPA actions and ensured the NCRs and CAPAs were closed in a timely manner. Participated in corrective and preventive actions reviews (CAR/ PAR).

Assisted the compliance team and led internal investigations related to product complaints. Analyzed historical data of customer complaints to detect and confirm the effectiveness of preventive actions.

Actively participated in regulatory inspections (Health Canada, U.S. FDA, etc.) as well as in client and internal audits. Operations Supervisor, Chemistry Dept. 2008 – 2010 Silliker Canada Co.: Toronto, Ontario

Maintained awareness of upcoming work and provided information to the analytical team to allow for optimum allocation of resources to meet client commitments. Planned and organized work by reviewing appropriate documents such as specifications, procedures and protocols, to ensure compliance and to assure quality outcome and output.

Reviewed and approved the data and results using Laboratory Information Management System (LIMS).

Worked with inter-disciplinary teams across organization to investigate, resolve and prevent quality issues.

Supported the development and preparation of retest/ repeat test protocols for OOS results on analytical methods and other special investigative study protocols and risk assessments.

Performed internal audits to ensure compliance with cGMP standards, site and corporate policies. Maintained audit records and documented follow-up of audits.

Developed and deployed GMP and other quality/ compliance training for staff.

Maintained regular contact with customers and clients regarding specific product related issues. Worked to ensure compliance of their products with approved standards and specifications.

Provided support to QA for product destruction per applicable SOPs. SHANTHIMATHY THIRUCHELVAM

25 George Martin Drive, Markham, Ontario, L3R 8V1

**********@*****.***

905-***-**** Cell: 647-***-****

Supervisor, Quality Control Dept. 2000 – 2008

Mylan Pharmaceutical Company: Toronto, Ontario

Supervised and trained staff.

Performed high level analytical data, reports and protocols review and supported product release.

Led and managed projects. Conducted laboratory work to complete projects on time and met the company objectives.

Supervised the investigations and troubleshooting activities using advanced analytical knowledge and experience. Prepared deviation reports. Reviewed and approved LIRs and deviation reports and followed up on CAPA completion.

Ensured controlled substance sample handling and distribution, including ensuring appropriate personnel and controls were in place.

Assisted in preparation of Annual Product Quality Reports (APQRs).

Led internal investigations and provided assistance for complaint investigations. Evaluated complaint reports for accuracy and completeness as per approved SOPs.

Prepared department monthly report and evaluated the turnaround time of the products. Conducted necessary investigation and follow up on products that exceeded the standard turnaround time.

Ensured the technological transfer of analytical methods from source labs to third party/contract testing labs; Coordinated outside testing with contract labs and maintained communication on a routine basis.

Experienced in all aspects of handling High Potent products, Benzodiazepines and other controlled substances. Performed AQPIC duties.

Senior Analyst, Quality Control Laboratory 1997 – 2000 Genpharm ULC.: Toronto, Ontario

Performed quantitative and qualitative analysis including assay, content uniformity, dissolution, degradation products, purity check, and residual solvents in accordance with cGMPs and cGLPs to ensure that the product meets the specification requirements for raw material, in-process and finished product samples. Assisted validation and stability testing. Conducted the laboratory investigation procedure for out of specification and out of trend results.

Reviewed data generated by analytical methods, laboratory investigation reports to ensure accuracy and compliance with established procedures. Communicated with contract labs for outside testing sample results and testing procedures and reviewed the data generated by them.

Reviewed GMP logbooks on a regular basis to ensure the completeness and good document practice.

Analyzed historical data (deviations, analytical failures, customer complaints) to detect/ establish trends and confirmed effectiveness of preventative actions.

Evaluated and completed investigation reports for out of specification results for finished product in a timely manner.

Wrote and revised change controls, protocols and SOPs and worked to according to strict guidelines and timelines. Reviewed and approved comprehensive change controls.

Shown sound scientific judgment and expertise in GMP requirements directly related to analytical testing.

Demonstrate excellent understanding and competence in using process control charts, linear regression and skills in interpreting and generating analytical data.

Acquired “hands-on” experience in using USP, BP, EP Pharmacopeias. Gained a very good understanding of all the SOPs, GMP regulations, FDA and ICH guidelines.

EDUCATION & PROFESSIONAL DEVELOPMENT

Bachelor of Science - University of Peradeniya

Accredited by University of Toronto as being equivalent to a Canadian B.Sc. degree

Industrial Pharmaceutical Technology Program - Seneca College, Toronto, Ontario Completed courses in HPLC, GC, Lab Assay Methods, Microbiology, Pharmaceutical Manufacturing, Pharmaceutical Formulation and Biochemistry

Certificates: GMP training; Corrective and Preventive Action (CAPA) systems; Effective problem solving & decision making; OHS for managers and supervisors; How to supervise people; How to handle people with tact and skill; Spill responder; Electronic compliance; Successful HPLC method validation & Method transfer

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