Resume

Sign in

Quality Safety Officer

Location:
Salmiya, Hawalli Governorate, Kuwait
Salary:
850 KD
Posted:
March 26, 2019

Contact this candidate

Resume:

ANIS MUSTAFA

Nationality

Indian

Date of Birth

Sept 19

th, 1984

Passport No.

Z3830218

Civil Id No.

284*********

Email:

ac8wp0@r.postjobfree.com

Mobile No.

+965-********

Skype ID

getanis20

Language Known

English, Hindi, Arabic,

Urdu, Gujarati & Punjabi

Address

Flat No. 15, Floor No. 4,

House No. 17502,

Street No. 101,

Block No. 3,

Hawally, Kuwait

OBJECTIVE

To contribute with all my professional skills towards the growth of the organization, with well-directed hard work and extreme dedication. Thus to create a distinct position in the Pharmaceutical field. TECHNICAL SKILLS

Quality Assurance/Quality Control activity

Preparing & Reviewing the SOP’s pertaining to

QA/Warehouse/Regulatory/Clearance/Purchase departments to ensure GMP/GDP compliance of systems, procedures and techniques.

Preparation and review of the Quality Manual, Quality Agreements, MFR, BMR/BPR, SMF, SSP, PDR and other relevant documents like MOA, COA according to USP, BP, EP & IH.

Reviewing the Temperature mapping protocol/reports of Warehouse/Cold room/Freezer as per EU/USP guidelines.

Preparation, Review & implementation of OQ/PQ of temperature mapping for delivery vehicles and cold chain delivery boxes.

Monitoring and Review of Qualification activities as DQ, IQ, OQ, and PQ of instruments and equipment’s.

Executing the Periodic calibration/validation of equipment’s & instruments in the warehouse and quality activities.

Maintain the quality systems such as Trend Analysis, Change Control, Product Recall, Returned goods, Disposal process of Expired items, Re- processing, QCL sampling, Out of Specification, Out of Calibration, Control of Non-conforming products/CAPA, Product Quality Reviews, Stock adjustments and Risk assessments.

Conduct & Evaluation of the EU-GMP/GDP trainings.

Handling of Quality & Non-quality market/customer complaints and counterfeit products.

Internal/External inspections and Perform Supplier Audits and Distributors Audits.

Ensuring the implementation of SOP’s to ensure GMP/GDP compliance of systems, procedures and techniques.

Sound knowledge of ICH, ISO, GMP, GLP, cGMP, EU-GDP regulatory practices and Operating knowledge of Dynamix, SAP, ORION, EDMS, EQMS, Windows 7/10, Adobe Acrobat and Office 365.

Regulatory Affairs activity

Preparation, Review & compilation of Dossier/DMF for registration in regulated, semi regulated & non-regulated countries. i.e. CTD, eCTD, ACTD, EMEA, MHRA as per the requirement of concerned MOH guidance.

Compiling / Writing & submitting regulatory documents in an efficient and timely manner.

Solving queries of customers related to Regulatory Affairs, DMF, CTD, MFR, etc and facilitate quick response to technical queries from various regulatory agencies.

CURRICULUM VITAE

RELEVENT EXPERIENCE

Presently working as QA-In Process Control Supervisor in Yiaco Medical Company, Kuwait from January 2016 to till date.

2 yrs 9 months as Sr QA Compliance Executive in Kuwait Saudi Pharmaceutical Company (KSPC), Kuwait.

18 months as Sr. RA Executive in BDR Pharmaceuticals International Pvt. Ltd, Vadodara, Gujarat, India.

6 months as Sr. QA Executive in Piramal Healthcare Ltd, Maharashtra, India.

One year as QA Officer in K A Malle Pharmaceuticals Ltd, Gujarat, India.

Team member and part of Successful audits of SGS EU-GDP, WHO-GMP, ISO, HACCP, SQF audit, and various routine principal audits from Sanofi-Aventis, GSK, Boehringer, J&J, Roche, etc. PROFESSIONAL QUALIFICATION

Master of Pharmacy in Pharmaceutical Chemistry, (2009), from ASBASJSM College of Pharmacy, Bela, Ropar (Punjab). Affiliated to Punjab Technical University, Jalandhar, Punjab, India with aggregate 73.38 % with Merit position in University.

ADDITIONAL QUALIFICATIONS

Registered Community Pharmacist S. No. 25568 in Rajasthan Pharmacy Council, Jaipur, Rajasthan, India.

Diploma in IPR from WIPO, Geneva, Switzerland.

Diploma in Pharma Management from IPER, Pune, India. SCHOLASTICS

Bachelor of Pharmacy, (2007), from B. N. College of Pharmacy, Udaipur (Rajasthan), Affiliated to Rajasthan University of Health Sciences, Jaipur, Rajasthan, India with aggregate 74.89 % with Silver Medal.

AREA OF INTEREST

Quality Assurance/ Quality Control Compliance/ Drug Regulatory Affairs EXTRAMURAL ENGAGEMENTS

Recipient of Best QA Team member and Certificate of Appreciation for SGS EU-GDP certification in Yiaco for the year 2016.

Recipient of Scholarship from Central Wakf Concil, New Delhi, India.

Secured 92% in National Level Pharmacy Talent Search Examination-2007, organized by Pharma Helpline Society, Jaipur, Rajasthan, India.

COMPETENCIES

Results driven, disciplined and excellent in multi-tasking

Maintaining excellent public/corporate relations with strong oral/written communication skills DECLARATION

I do hereby solemnly affirm that all the statements and information furnished above are true, complete and correct to be the best of my knowledge and belief.



Contact this candidate