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shakeelashareef

Shakeela Shaif

@shakeelashareef

Chemist,Pharmaceutical and Agricultural Industry Experience

Pakistan
Inglese
Alcune informazioni sono riportate in lingua inglese.
Chi sono
I am a chemist with 5 years of industrial experience in the pharmaceutical and agricultural sectors. I have hands-on experience with SDS/MSDS, COA, SOPs, QA/QC documentation, regulatory compliance, DRAP submissions, dossier preparation and review, and agricultural chemical documentation. I provide support with chemical documentation, regulatory documentation, scientific research, literature reviews, and chemistry and biology-related academic assistance. I focus on accuracy, confidentiality, and well-organized work.... Continua a leggere

Competenze

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shakeelashareef
Shakeela Shaif
offline • 

Consulta i miei servizi

Certificazioni e regolamenti
I will provide pharmaceutical regulatory and quality support

Esperienza lavorativa

Group

Chemist

Group • Full time

Oct 2024 - Jan 20261 yr 3 mos

Performed advanced analysis of micronutrients, fertilizers, and pesticides using GC, HPLC, UV-Vis, Kjeldahl apparatus, atomic absorption, flame photometry and hands-on experience with LCMSMS. Assisted in the development and optimization of new testing methods and lab technologies. Ensured compliance with ISO 17025 and ISO 9001 standards, maintaining detailed documentation of lab procedures and results. Contributed to quality audits and lab accreditation processes, managing records as per regulatory requirements. Implemented best lab practices and protocols, ensuring accuracy and efficiency in testing and reporting using MS Word and Excel.

Citi_Pharma Limited

Citi Pharma Limited

Full time • 3 yrs 3 mos

Quality Control Analyst

Jan 2023 - Oct 20241 yr 9 mos

Performed quality control testing of raw materials, in-process samples, and finished pharmaceutical products. Conducted chemical and physical tests according to approved SOPs and pharmacopeia standards. Prepared and analyzed samples using laboratory equipment and instruments. Maintained accurate laboratory records, test results, and documentation in compliance with GMP requirements. Monitored product quality and identified deviations or out-of-specification (OOS) results. Assisted in investigations of quality issues and implemented corrective and preventive actions (CAPA). Followed Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), and laboratory safety procedures. Coordinated with production and quality assurance teams to ensure compliance with quality standards. Supported internal and external audits by maintaining complete and organized quality documentation.

Regulatory Affairs Officer

Jul 2021 - Jan 20231 yr 6 mos

Ensuring compliance with regulatory requirements and standards. Managing and preparing dossiers, such as the Common Technical Document (CTD) and Drug Regulatory Authority of Pakistan (DRAP) submissions. Reviewing documentation for regulatory compliance. Preparing dossiers for export purpose and DRAP submissions. Keeping up-to-date with regulatory guidelines and changes in regulations. Manage queries from DRAP regarding Dossiers shortcomings. Responding to regulatory inquiries and addressing any compliance issues. Responding to DTL and PQCB letters. Participating in regulatory inspections and audits. Ensuring the accuracy and completeness of regulatory documentation. Perform other tasks as delegated by Regulatory Management.