Syed Arifuddin Salman
Baltimore,MD
Summary
Professional Summary.
Turning deviations into opportunities for improvement, I specialize in investigating root causes, implementing CAPAs, and driving compliance at Catalent Pharma Solutions. With a keen eye for process optimization and regulatory adherence, I collaborate closely with production, quality control, and regulatory teams to ensure the timely resolution of deviations while maintaining cGMP, FDA and EMA compliance.
My expertise in Quality Management Systems (QMS), deviation tracking, and risk assessment has strengthened manufacturing consistency and regulatory readiness. By leading impact assessments, trend analyses, and training initiatives, I have helped create a proactive quality culture that minimizes errors and enhances operational efficiency.
From audit support to continuous improvement initiatives, my ability to translate technical findings into actionable solutions ensures that pharmaceutical products meet the highest quality and safety standards.
Overview
2
2
years of professional experience
Work History
Manufacturing Technical Writer (Deviation)
Catalent
Harmans, MD
10.2022 - Current
- Collaborate with production, quality control, and regulatory affairs teams to investigate and document deviations from established procedures.
- Lead deviation investigations to identify root causes, and implement effective corrective and preventive actions (CAPAs) to prevent recurrence.
- Ensure timely initiation, documentation, and closure of deviation investigations, following internal procedures and regulatory guidelines.
- Review and assess the impact of deviations on product quality, safety, and regulatory compliance.
- Generate deviation reports and communicate findings to relevant stakeholders, including management, and regulatory agencies when necessary.
- Participate in risk assessments related to deviations, and recommend appropriate mitigation strategies.
- Collaborate with manufacturing and quality teams to ensure that deviations are properly tracked, trended, and addressed.
- Contribute to the development and implementation of continuous improvement initiatives to reduce the occurrence of deviations.
- Stay updated with industry regulations, guidelines, and best practices related to pharmaceutical manufacturing deviations.
- Provide training and guidance to manufacturing personnel on deviation reporting and investigation processes.
- Assist in audits and inspections related to deviations by providing documentation and explanations.
- Conducts investigations, root cause analysis, and implements CAPAs.
Education
Master of Science - Engineering Management
Trine University
Angola, INSkills
- Technical Writing and Documentation
- Good Documentation Practices (GDP) and Regulatory Compliance
- Quality Management Systems (QMS)
- Manufacturing process documentation
- Process Improvement and Lean Manufacturing
- Deviation and CAPA documentation
- 21 CFR Part 11 and Data Integrity Compliance
- Standard Operating Procedures (SOPs) and Batch Record Authoring
- Technical Review and Editing
Timeline
Manufacturing Technical Writer (Deviation)
Catalent
10.2022 - Current
Master of Science - Engineering Management
Trine University
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