Farhat Shaikh Email & Phone Number

Bharuch, Gujarat, India

• Handling of Deviations: Scientific evaluation of deviations, providing data for quality review, execution of root cause analysis, risk assessments and define corrective measures• Review, assigning, closing & compliance of corrective & preventive actions (CAPA)• Preparation, review & approval of “Process performance qualification protocols & reports”• Handling of market complaints: Review and approve the investigation, implementation of CAPA, if any and closure.• Ensuring adequate support and requirement of documents in case of FARs and recalls• Handling of OOS / OOT Phase: II investigations: Investigation and review of phase – II investigations.• Process Validation: Preparation and review of process performance qualification protocols and reports.• Quarterly / half yearly Trending and review of product complaints and deviations for Continuous Quality improvement.• Reviewing the external and internal audit observations and ensuring the compliance level at the site

India

• Evaluate Deviations, Change controls, Complains, Out of specifications, Out of trends, CAPAs, Internal audit findings, External audit findings and propose corrective and preventive actions• To review and approve Annual Product Quality Review and to Assure Continuous Quality improvement in plant related to trends from Quality systems • Conducting cGMP and On-job Training programs, vendor audits and internal audits• In charge of carrying out validation of HVAC (ISO Class 7 and 8), Validation of processing equipment (Manufacturing tank, Filling machine, Batch coding machine, Ethylene Oxide Sterilizer, Freeze Dryer) and Facility Qualification• To Prepare and review validation documents, URS, DQ, IO, OQ, PQ, Performance verification, FAT, SAT protocols and reports• Planning and execution - Process validation of Liquid formulations and Wound Dressings• Successfully faced cGMP, CDSCO, ISO 9001 and ISO13485 audits• Co-coordination with regulatory department for addressing non-conformities and providing CAPA against the same• Lead team of four QC chemists and two QA officers• Worked with management to resolve project issues and resource constraints within team• To register non-conformities observed in plant and discussion of quality problem with senior management.

Vadodara Area, India

• Guided Post Graduate students for o Prospective Process Validation of film coated tablet containing Calcium Citrate malate, Folic acid and Vitamin D3 at Bajaj Healthcare LTD.o Process Validation of compressed tablet containing Omeprazol magnesium and Domperidone at Cadila Pharmaceutical Ltd., Dholka o Process Validation of Tablet Dosage Form containing Dried Aluminium Hydroxide, Magnesium Hydroxide and Simethicone in Pharmaceutical Industryo Development and Validation of analytical method(s) for combination dosage forms using HPLC,HPTLC and GC • Academic Experienceo Prepare and deliver lectures, tutorials and practical classes for undergraduate and postgraduate students.o Supervise research students and discuss with students their progress and/or aspirationso Organize and conduct field trips and excursions or other learning activitieso Attend meetings and conferences related to research and academicso Plan courses in consultation with other staff, arrange course timetables and coordinate and supervise teaching assistants to conduct classeso Serve on departmental or faculty committees dealing with general departmental and administrative concerns with University.

Vadodara Area, India

• Assisted with enrolment, orientation, and retention of students of institution. Informed economically-weak students about institution-sponsored financial packages and assisted them in getting appropriate fiancial assistance. • Implemented, recorded and monitored training programs and activities for students. • Networked and developed contacts with school, college and university partners, funding partners and sponsors. • Evaluated, monitored and assisted in improvement of student progress and student development. • Attended regular meetings with student and families to identify and discuss their needs and concerns. • Assisted with updating and maintenance of students database. • Providing secretarial services such as minute taking, WP and diary management. • Ensuring office procedures and systems operate efficiently.• Handling requests for information and data.• Circulating documents via post and email.• Scanning and copying contracts, notes and other documents.• Recording, compiling, transcribing and distributing the minutes of meetings.

India

Advanced Diploma, Drug Regulatory Affairs

Doctor Of Philosophy - Phd, Pharmaceutical Science

Master Of Pharmacy, Quality Assurance, Distinction

Worked on ' Development and validation of analytical methods for estimation of constituents in polyherbal formulation' along.

Bachelor Of Pharmacy (Bpharm), Pharmaceutical Sciences, First Class

As a student of pharmacy education has thoroughly studied principles of drug design, Recent advances in computational drug design.