プロフィール詳細

プロジェクトを作成

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Muhammad A.に依頼

Pakistan

Sinor Pharmaceutical QA and Regulatory Compliance Specialist

プロフィール概要

> Pharmaceutical QA & Regulatory Compliance Specialist | 5+ Years Industry Experience > I am a dedicated Quality Assurance professional with a 5-year track record in the pharmaceutical manufacturing sector. I specialize in maintaining GxP compliance and driving quality excellence through robust documentation and risk-based decision-making. > Key Areas of Expertise: > * Quality Management Systems (QMS): Comprehensive experience in managing deviations, change controls, and CAPA systems to ensure continuous process improvement. > * Technical Writing: Expert in drafting and reviewing Standard Operating Procedures (SOPs), Validation Protocols (IQ/OQ/PQ), and Site Master Files (SMF) in alignment with ICH and local regulatory guidelines. > * Risk Assessment: Proficient in using FMEA and RPN methodologies to assess the severity of manufacturing deviations and implement effective mitigation strategies. > * Audit Readiness: Skilled in performing internal quality audits and preparing facilities for regulatory inspections to ensure zero-non-compliance. > I am committed to providing high-quality consulting and technical writing services to pharmaceutical startups, CMOs, and global manufacturers looking to enhance their quality standards.

専門分野

• ☆ Pharmacy
• ☆ Pharmacy Education
• ☆ Pharmaceutical Regulatory Affairs
• ☆ Pharmaceutical Manufacturing
• ☆ Pharmaceutical Management
• ☆ Quality Assurance & Quality Control (QA/QC)

サービス

• Writing
• Consulting

Writing Technical Writing

Consulting Scientific and Technical Consulting

職務経験

PDH laboratories

- 現在

Sinor Officer QA

Salbion Health Sciences

11月 2020 - 1月 2026

学歴

Pharm-D (Pharmacy )

Rashid Latif Medical College

2月 2014 - 12月 2019

認定資格

• Pharm-D degree

  University of Sargodha

  http://degreecell.su.edu.pk:88/

  7月 2020 - 現在