Compliance Analyst Team Member
Resume:
CURRICULUM VITAE
ANIS MUSTAFA
Nationality
Indian
Date of Birth
Sept 19th, 1984
Passport No.
Z3830218
Email:
*********@*******.***
Mobile No.
Skype ID
getanis20
Language Known
English
Hindi
Arabic
Urdu
Gujarati
Punjabi
OBJECTIVE
To execute all my professional skills in the Quality & Compliance section & contribute towards the growth of the organization and create a distinct position in Pharmaceutical & Medical field. PROFESSIONAL RESPONSIBILITIES
Quality Assurance/Quality Control activities
Responsible for preparation & review of the SOP’s pertaining to QA/Logistics/Regulatory/Clearance/Purchase departments to ensure GMP/ GDP compliance of systems, procedures and techniques.
Responsible for preparation and review of the QMS documents including Quality Manual, Quality Agreements, Master Formula Record, Batch Manufacturing/Packaging Record, Site Master File, Stability Study Protocol, Product Development Report and other relevant documents like Method Of Analysis, Certificate Of Analysis (as per USP/BP/EP/ICH Pharmacopoeia).
Responsible for reviewing the temperature mapping reports of warehouse/cold room/freezer/delivery vehicles as per EU/USP guidelines.
Responsible for monitoring and review of validation activities as Process validation/Cleaning validation of pharmaceutical products & equipment’s.
Responsible for monitoring and review of qualification activities as DQ, IQ, OQ and PQ of analytical/process instruments and equipment’s.
Responsible to oversee the calibration and precision of quality control tools and equipment’s.
Been a Team leader was instrumental in the implementation of 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 based on key Quality KPI’s.
As a certified Trainer, to conduct the EU-GMP/GDP trainings sessions as per the operational requirements for all employees.
Responsible for handling of Quality & Non-quality market/customer complaints and management of counterfeit products.
Performed Internal/External in-house inspections and Supplier/ Distributors/3rd party audits.
Business Compliance activities
Responsible for preparation & review of 3rd party service contracts and execution of non-trade supplier qualification process.
Responsible for developing compliance procedures/policies as Quality, Safety, Anti-Bribery & Anti-Corruption and Code of conduct in compliance with GxP procedures, company standards or customer requirements.
Trained employees on the company’s ABAC & Code of Conduct policies.
Responsible to maintain internal control mechanisms and corporate to regulate business processes in line with compliance requirements to ensure the company’s adherence to international anti-bribery and anti-corruption laws and monitor business activities to ensure continuous compliance.
Active participation in committees, task forces and teams related to maintain corporate policies with regards to business compliance and/or performance improvement plan.
CURRICULUM VITAE
Regulatory Affairs activities
Responsible for preparation, review & compilation of CTD Dossier / Drug Master File for registration for regulated, semi regulated & non-regulated markets i.e. CTD, eCTD, ACTD, EMEA, MHRA as per the requirement of concerned MOH guidance.
Responsible for compiling / writing & submitting regulatory documents in an efficient and timely manner.
Instrumental in solving queries of customers related to regulatory dossiers, DMF, CTD, MFR, etc and facilitated quick response to technical queries from various regulatory agencies. PROFESSIONAL EXPERIENCE
Presently working as Quality Assuarance & Compliance Officer in Alghanim Healthcare Company, Kuwait from December 2018 to till date reporting directly to CEO.
Worked for 3 years (01/2016-12/2018) as QA-In Process Controller Supervisor in Yiaco Medical Company, Kuwait.
Worked for 2 yrs 9 months (03/2013-12/2015) as Sr. QA Compliance Analyst in Kuwait Saudi Pharmaceutical Company, Kuwait.
Worked for 18 months (09/2011-02/2013) as Sr. RA Executive in BDR Pharmaceuticals International Pvt. Ltd, Vadodara, Gujarat, India.
Worked for 6 months (02/2011-08/2011) as Sr. QA Executive in Piramal Healthcare Ltd, Maharashtra, India.
Worked for 1 year (01/2010-01/2011) as QA Officer in K A Malle Pharmaceuticals Ltd, Gujarat, India. PROFESSIONAL QUALIFICATION
Master of Pharmacy in Pharmaceutical Chemistry, (2009), from Punjab Technical University, Jalandhar, Punjab, India with aggregate 73.38 %.
ADDITIONAL QUALIFICATIONS
Registered Community Pharmacist S. No. 25568 in Rajasthan Pharmacy Council, Jaipur, Rajasthan, India.
Diploma in Intellectual Property Rights (2008) from WIPO, Geneva, Switzerland.
Diploma in Pharma Management (2006) from IPER, Pune, India. TECHNICAL / COMPUTER SKILLS
Well versed in International quality guidelines as ICH, HACCP, ISO 9001-2015, cGMP, GLP & EU-GDP procedures.
Microsoft Office (Word, Excel, Access, Visio, Project, PowerPoint, Outlook, Office 365); Adobe Professional; Lean Six Sixma Principals.
ERP system as Dynamix, SAP, ORION and Quality system as EDMS, EQMS. COMPETENCIES
Project and time management skills Leadership, coaching and mentoring skill
Interpersonal and communication skills Lead QMS Auditor
Critical thinking and problem solving Strategic planning and decision making
Ability to Work under Pressure Result oriented, initiative, proactive Team player EXTRAMURAL ENGAGEMENTS
Recipient of Best QA Team member (2016) and Certificate of Appreciation for SGS EU-GDP certification in Yiaco Medical Company, Kuwait.
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.
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