Danish D.
Qc Supervisor @Bimeda
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WORK HISTORY
Qc Supervisor @Bimeda
Supervises the QC testing laboratory staff and oversees the processes for analytical testing of raw materials, in-process, finished product and stability samples.• Ensures that all work is carried out in compliance with company Safety policies, Good Manufacturing Practices (GMP/GLP) and Standard Operating Procedures (SOPs) and escalates related issues to QC Manager on timely manner.• Achieves results through direct reports by communicating job expectations; establishing individual goals in line with departmental objectives, coaching, reviewing performance results; holding accountable; providing cross training opportunities for skill development.• Leads by example and proactively communicates and collaborates with internal staff and colleagues to achieve objectives.• Reviews laboratory documentation in notebooks, attachments, chromatography software, and specification sheets for accuracy, completeness, and compliance with established SOPs, specifications and methods.• Review stability protocols for scale-up and ANA/NDA products.and assists in the creation of the test schedule for the QC team.• Compiles data to trend and monitor key department performance metrics and provides reports to manager as required• Initiates deviation reports for any applicable nonconformances. Works with other departments and leads QC investigations to ensure accuracy and completeness of out-of specifications, out-of-trends, deviations, and non-conformances.• Oversees the training of laboratory staff on newly written or revised methods and procedures• Acts as the primary point of contact for laboratory investigations information with internal and external auditors and regulatory inspectors in the absence for the QC Manager.• Leads in the implementation of continuous quality improvements, CAPEX projects and lean laboratory initiatives in accordance with GLP.• Develops, reviews and revises laboratory documentation, Initiates change control documents as required
EDUCATION
Durham College
Pharmaceutical Chemical Lab Technology
Canadore College
Health Care Administration , Health/Health Care Administration/Management
Punjab Technical University
Bachelor's degree, Pharmacy
ABOUT DANISH D.
I am a passionate, confident and pro-active chemist with proven skills and knowledge in operating variety of analytical instruments.*Experienced Chemist with In-depth demonstrated working experience of automatic as well as manual Analytical instruments such as DSC, HPLC, GC, ICP-MS, IR, ATR, UV-VIS,Particle Size, KF using various softwares such as Empower3; Spectrum; Nexion, LIMS7; SAP etc.*Always followed strict GxP guidelines and industrial regulations to practice cGMP.*Gained operational and interpreting skills on various analytical instruments and techniques such as TLC, NMR, Karl fisher.*I would like to take on new challenges which will allow me to utilize the skills I possess while providing a platform to learn from other professionals in order to grow personally and professionally as well.https://ca.linkedin.com/in/danish-d-9163b3183
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