Hitesh Chopra

About Hitesh Chopra

With a decade of in-depth experience in the pharmaceutical sector, I have honed my skills…

Experience

1. Head of Quality

   Hitech Formulations Private Limited

   Dec 2022 — Present

   QA Responsibilities:• Formulate and oversee the execution of the Quality Management System, including SOPs, Change Control, Deviations, Incidents, CAPAs, and Product Complaints• Maintain real-time documentation and review batch records in line with defined procedures• Set strategic goals for the QA team to enhance efficiency and drive cost reduction measures• Manage the rejection and disposal process for materials and oversee proposed reworks• Maintain comprehensive documentation for the QA/QC departments• Coordinate activities such as change control, deviation management, and batch release• Design and implement action plans for CAPA initiation, ensuring thorough resolution of issues before audit deadlines• Inspect and validate Artwork/BMR/BPR during production stages prior to final product dispatch• Ensure the seamless flow and periodic inspection of materials and documents to vendors• Conduct quality checks to minimize errors in product processesQC Responsibilities:• Thoroughly review and verify R&D related analytical data, ensuring regulatory submission standards are met• Validate calculations and all recorded information including reagent expiry and instrument calibration• Issue and oversee the maintenance of Certificates of Analysis (CoAs)• Manage and reconcile laboratory workbooks and logbooks• Ensure all analytical activities comply with standard methodologies and regulatory requirements (GLP and GMP)• Review and update Standard Operating and Testing Procedures (SOPs and STPs)Compliance Responsibilities:• Implement and maintain a proactive quality system aligned with cGMP standards• Review and analyse QC laboratory investigations• Update and standardize key Quality Documents and ensure adherence to the Quality Policy• Conduct thorough reviews of analytical records before final batch dispatch• Regularly assess training records, SOP adherence, and manage Change Control systems

Skills

• Powerpoint
• Microsoft Excel
• Uv/Vis
• Glp
• Pharmaceutics
• Good Laboratory Practice (Glp)
• Regulatory Affairs
• Lifesciences
• Hplc
• Formulation
• Technology Transfer
• Pharmacovigilance
• High-Performance Liquid Chromatography (Hplc)
• Gmp
• Uv/Vis Spectroscopy
• Particle Size Analysis
• Amv
• Uv
• Biotechnology
• Pharmaceutical Industry
• Sop
• Standard Operating Procedure (Sop)
• Ftir
• Adl
• Drug Delivery
• Gc Ms
• Gas Chromatography
• Validation
• Uplc