Sohrab Sarker

**** ***** ***** **. *****: 714-***-****

Anaheim, CA 92805 email: adwi9w@r.postjobfree.com Quality Assurance Specialist with 18 years’ experience working in a GMP environment, maintaining Title 21 CFR Part 111, 210/211 requirements to overcome regulatory burden. Successfully capable to handle FDA issued 483 corrective action report timely manner. Able to create time to time SOP if requested by any regulatory agency like NSF, UL or food safety auditor to meet their requirement for GMP certification processes as well as FSVP of FSMA. Looking to work with any bioscience company where I can execute my educational knowledge and experience properly to be a part of successful production/QA-QC team member. Work history

QA Specialist April 2005 - January 2023, Sun Ten Laboratories, Irvine, CA 92618 As a QA Specialist, specialized in regulatory affairs, maintaining cGMP documentation, sole responsible to taking care of any regulatory aspect, GMP & other certification and also closely working with production/packaging/QA- QC team members for production, packaging and testing issues and solve their daily need as needed.

QA/QC Associate December 1994 – August 1995 Beximco Pharmaceutical Ltd, Bangladesh. Incoming raw ingredients/finished product checking, sampling, testing and releasing if meet the specification. Checking in process product quality, following SOP and maintaining documentation. Skills & Experiences

• Monitoring raw material sampling/reviewing test report and approved for releasing.

• Reviewing and approved the finished product label for packaging.

• Reviewing and approved master batch record and in process batch record for production.

• Double checked, final production batch record for filling to make sure every stage is properly signed and dated by the performer and yield is within the limit.

• Handle customer complaint and able to handle Mock recall procedures.

• Properly report OOS for any deviation of production, label claim and test result if any.

• Knowledge of machine suitability (IQ,OQ, PQ), CAPA and PM for machine.

• Created SOP or any other documentations as needed.

• Monitoring Vehicle inspection documentation for shipping/receiving.

• Monitoring pest control, temperature, humidity, building/premise logbook.

• Oversees monthly Internal, sanitation and cleanliness audit for GMP area.

• New label reviewed to meet FDA label requirements for DS and nutraceutical food product.

• Learn, train and enforce to follow cGMP guideline in every step of production/packaging/receiving/shipping and releasing steps.

• Communicate effectively with proper reporting personnel timely manner and carry out their instruction as instructed.

• Familiar with Labs reagent and equipment like FT-IR, HPTLC, HPLC, GC and LC-MS, ICP-MS, microbial contaminations and it’s limit test.

• Investigated and report any incident and handle food safety certification processes

• Can create finished product and raw material specification as needed.

• Can be helpful to assist sales to get new business opportunity and open a possible new product line.

• Specialist in food safety certification processes with solid dosages HACCP Plan of Dietary Supplement products.

Education

M Sc. in Organic Chemistry, Rajshahi University, Rajshahi, Bangladesh, 1985 - 1990 References

1. Dr. Zaman, Cell 562-***-****, 4Excelsior Pharma, Anaheim, CA 2. Ayub Khan, Cell 714-***-****, Bio Rad, Irvine, CA