Skills

Dear Sir/Madam, 

I have total 08 year experience in pharmaceutical industry. Currently, I am looking for job. I can work in production, quality assurance, QMS, IPQA, qualification, validation and regulatory department. 

I am ready to relocate myself if give me an opportunity to work with your organization or please recommend me to work in your organization. 

Please contact me if I short- listed for your organization. 

I will never forget your thanks. I will never let you down. 

Job Responsibility

1. Job related to formulation:

 In-process quality assurance activity during routine plant operation like dispensing, granulation, compression, coating and packing stage.

 Execution of the activity as per BMP, BPR and other validated document.

 Perform verification and calibration activity as per calendar VMP schedules for IPQA instrument.

 Preparation, issuance, revision, review, release, archival and retrieval of BMR, BPR, SOP, protocol, innovative & retain sample, labels and other master document.

 Performing and manage of all warehousing activity as per GMP regulation like material return note, gate inward material, issuance, record, arrangement, coding system and cleaning etc

 Review and approve BMR, BPR, SOP, Analytical method validation, process validation, cleaning validation, stability protocol and report, specification and standard test procedure against ICH and related pharmacopeias.

 Preparation of SOP for specific task and conduct the training for staff awareness.

 Prepare shift schedule, work allocation as per skill and review daily work report of employee and improve their work efficiency by training and suggestion.

 System up-gradation as per current ICH, cGMP and FDA guideline.

2. Job related Validation:

 Prepare and execute the validation activity as per validation master plan.

 Prepare and execution of protocol and report for process validation, cleaning validation activity and all tests involve in HVAC validation (clean room area qualification) and RLAF qualification.

 Qualification and cleaning validation of RLAF (reverse laminar air-flow), performing dirty equipment hold time study (DEHT) and cleaned equipment hold time study (CEHT) of different equipments.

 Prepare and execution of URS (user requirement specification), IQ (installation qualification), OQ (operational qualification) and PQ (performance qualification) protocol and report of various manufacturing and packaging equipment of solid oral and parenteral product (Including manufacturing and packing machine).

 Performed FAT and SAT for new machine with latest technology as when required as specially for PLC and SCADA system validation.

 Having depth knowledge related to dry heat, gas, moist heat sterilization process and also validated Autoclave, Bung Processor, Getting, ETO and Hot Air Oven Sterilizer.

 Visual inspection process for parenteral has been performed as per KNAPP test guideline.

 Performed media fill validation for liquid and dry powder line with different intervention.

 Cross-contamination study for penicillin and beta-lactum product.

 Temperature monitoring activity and identification of hot spot of area.

 Establishment and maintain water system for solid oral plant and parenteral plant. Performing various tests as regular interval and maintain the trend data for purify water and WFI (water for injection).

 Nitrogen and compressed air validation, air & liquid HEPA filter integrity test.

3. Job related QMS system:

 Daily monitoring temperature and % RH of the stability chamber.

 Preparation and execution of protocol and report for Hold time study and stability study review their analysis report at periodic interval.

 To observe any significant change during stability study and fill up the OOS form for the stability fail product.

 Performing all the activity related to retain sample room and stability chamber.

 Periodically observe the description of the control sample and fill up the un-conformity form for the specific product

 Preparation of protocol and report of risk assessment for individual product along with different equipment, GMP area and laboratories.

 Handling change control, planned and un-planned deviation and prepare APQR annually for every product with statistical assessment.

 To perform internal audit for each department. Prepare and execute validation master plan and site master file for auditor.

Refrences

 Currently, I am working in Intas Pharmaceutical Limited, SEZ in validation/qualification department as a QA – Sr. Executive since May-2017.

 Intas Pharmaceutical Limited, SEZ limited is 100.0% export the product in USA and UK.

 Product are in the form of tablets, capsule, parenteral and syrup. Most products are anti- cancer, anti-biotic, anti-epileptic and anti-depressant.

Previous organization

 I have worked in Lincoln Pharmaceutical Limited as a QA-Executive in validation department from Jan-2014 to May-2017.

 Lincoln Pharmaceutical has more than 350 product (tablet, capsule, parenteral, ointment, powder and syrup) export in African region, Brazil, Australia, middle-east and European country.

 I have worked in Amneal pharmaceutical limited as a QA-officer in IPQA department from Sep - 2011 to Dec-2013.

 Amneal pharmaceutical limited is 100.0% export the product in USA and UK.

 I have worked in Cadila pharmaceutical limited as a QA-apprentice in IPQA department from Feb - 2011 to Sep - 2011.

Time and Spatial Flexiblity

I am always ready to relocate myself to my job place. I potencially like to work in europe, china and canada region.

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