Ninad Sheth Email & Phone Number

Brampton, On, Ca

130 East Drive, Brampton

1) Support to Regulatory compliance and audit readiness:-- Create, review and write procedures for establishment of QC process- Support and perform out-of-specification investigations to establish root cause and help in implementation of CAPA.-Responsible for meeting the overall quality compliance objectives of the organization including accountability for all activities and tasks to be performed in manner to ensure compliance and best practices in cGMP.2)Support productivity targets :-- Schedule workload to perform all operation and work within the required metrics for turnaround times and adherence to schedule, organize work teams to accommodate testing requirements.- Accomodate operational priorities-Provide technical troubleshooting of issues.3) Support operational excellence within QC-Provide required analytical support for validation, compendia update (Method verification) and new initiatives-Review current systems and procedures and implement changes where appropriate to improve accuracy and efficiency.-Review potential for new technologies-Lead the special project like vendor evaluation, reduce testing.-Lead and mentor direct reports including ongoing coaching, performance feedback and career development.-Provide technical expertise to stakeholders4) Department metric- Actively participating in PROBOS and ASPIRE project.- Assist in Raw-material certification process

150 Signe Drive

1) Technical- Prepares test samples according to established in-house and compendia methods. Sets up and operates automated laboratory instrumentation such as HPLC, AA, dissolution and complex GC, as required. - Performs complex instrumental and wet chemistry tasks such as complex GC and HPLC investigations, adaptation of newest USP/BP/EP compendia methods into Apotex format, GF/FIAS AA techniques and Hg/Sn/Se-type analysis as required.- Modifies and validates compendia methods to suit testing of various raw materials and participates in method transfer activities at the Signet site. - Involved in the evaluation of new raw materials (from new supplier) and excipients with respect to performance of current analytical methods, when required.- Interprets and documents all test results, calculations and observations and completes comprehensive reports as required. - Utilizes technical expertise to troubleshoot on more complex, problematic products.- Recognizes OOS or out of trend results and completes lab investigations under minimum supervision.- Provides technical troubleshooting support/coaching and/or training to other chemists where appropriate. Uses knowledge of GMP to assess impact on compliance, provides recommendations on appropriate testing to supervisor and works collaboratively for resolution.- Prepares weekly schedules and task assignments to support Manufacturing activities and ensure deadlines are met under minimal supervision.2) Supervisory responsibility:-- In the absence of the supervisor, approves and reviews the laboratory testing data prior to the release of raw materials for production or drug product as required.- Works as an effective team member to meet departmental goals and is able to take on departmental leadership role in the absence of the supervisor

Canada

- Analyze organic and inorganic compound to determine chemical and physical properties, composition, structure by utilizing various wet chemistry, spectroscopic and chromatographic technique.- Performed calibration of laboratory equipment.- Troubleshoots on instruments to determined what might be impeding analysis.- Managed and handled Quality control reference standard.- Informed team leader in regards to the out of specification result and help tofind our the root cause of OOS result.

Ahmedabad, Gujarat, India

- Performed literature search and review the compendia and API supplier's DMF for various project.- Planned and conducted analytical chemistry activities associated with the development and testing of generic and innovative drugs.- Participated in technology transfer of validated method from ADL to QC.- Validated method related to assay, related substances, dissolution, content uniformity for drug substances and formulated products.

Halol, Gujarat, India

- Performed Method validation activities of ANDA product.- Managed stability studies of multiple markets.- Performed stability studied of R&D products particularly injectable and ophthalmic product.- Actively involved in maintenance and procurement of reference standard and in-house working standard.- Reviewed investigation report for OOS.- Successfully completed Nasal spray project by working closely with SPARC.

Science

Msc, Chemistry