Experience

ACI HealthCare Limited

• Bangladesh
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Sr. Executive Reviewer

  • May 2022 - Present

  •Responsible for Reviewing all Analytical Documents in Quality Control Laboratory and Physical Monitoring to ensure that all data generated in the laboratory are attributable, legible, contemporaneously recorded, original, accurate, complete, consistent, enduring, and available.•Regular review of Quality Control (QC) documents after every analysis to confirm zero tolerance for Data Integrity.•To comply with the requirements of Good Documentation Practice and ALCOA principle in QC area.•To review Application Level/Project Level Audit Trail, Method Audit Trail, Result Audit Trail, Sequence Audit Trail, Transaction log/System error log along with the respective analysis.•Participate in or lead all QC-related deviations, incidents, and OOS that are addressed and investigated properly.•To prepare a statistical report on regular frequency as specified in the standard process which should be used to uncover any underlying issue with the instruments, laboratory systems, or data integrity program.•To ensure QC equipment, spread sheets, calculators in routine use are qualified, verified, and calibrated.•To prepare SOPs in compliance with relevant guidelines of DGDA, WHO, USFDA and Company’s Quality Modules and Quality Manuals.•To prepare databases and trend chart of OOS, OOT and Analytical Incidents. •Works with other departments to proactively build quality into the processes and systems.•Complete Corrective and Preventive Actions (CAPA’s).•Initiate, and follow through with actions required to close Change Controls.•Participate in Internal, Customer and Regulatory Audits and Provide support for Regulatory Inspections.•May be required to deliver technical training programs.•Assist personnel with documentation issues and provides coaching and guidance to Quality Control team.•QMS and release related activity performed in NOVATEK QMS software system (RM & FP Module). Show less

• Sr. Executive QC

  • Jun 2019 - Apr 2022

  •To perform plan and analysis of incoming finished products, in-process materials, water and Stability samples as per approved analytical methods as per plan within required timelines.•To preformed analytical method validation and verification also cleaning validation.•To operate & maintain laboratory equipment as per approved SOP. •To record all data in the analytical data sheet timely & accurately.•To provide input in relevant log book and other data sheet in a timely manner and incompliance with SOP for good documentation practices. •To conduct timely execution of calibration (Agilent HPLC & UPLC, UV, Dissolution, Balance, pH meter etc.) / qualification / preventive maintenance of different analytical instruments and equipment as per procedure specified in approved SOP.•To performed spreadsheet validation and Module preparation of Analyst qualification.•To conduct process validation of upcoming R&D, TT and Toll manufacturing projects.•To prepare, update & review SOPs, Specifications, Testing Procedures, ADS, Protocols and Certification of Analysis etc. in compliance with relevant guidelines of DGDA, WHO, USFDA, ICH and Company’s Quality Module & Quality Manual.•To support regulatory submission by execution of different analytical work, preparation and review of analytical documents within required timelines.•To prepare databases and trend chart of OOS, OOT and Analytical Incidents. •Initiate, and follow through with actions required to close Change Controls.•To update supervisor / head of QC immediately whenever any OOS /OOT/Deviation/Non-Compliance is noticed. Show less

• QC Executive

  • Mar 2017 - Jun 2019

  •To perform plan and analysis of incoming finished products, in-process materials, water and Stability samples as per approved analytical methods as per plan within required timelines.•To preformed analytical method validation and verification also cleaning validation.•To operate & maintain laboratory equipment as per approved SOP. •To record all data in the analytical data sheet timely & accurately.•To provide input in relevant log book and other data sheet in a timely manner and in-compliance with SOP for good documentation practices. •To conduct timely execution of calibration (Agilent HPLC & UPLC, UV, Dissolution, Balance, pH meter etc.) / qualification / preventive maintenance of different analytical instruments and equipment as per procedure specified in approved SOP.•To performed spreadsheet validation and Module preparation of Analyst qualification.•To conduct process validation of upcoming R&D, TT and Toll manufacturing projects.•To prepare, update & review SOPs, Specifications, Testing Procedures, ADS, Protocols and Certification of Analysis etc. in compliance with relevant guidelines of DGDA, WHO, USFDA, ICH and Company’s Quality Module & Quality Manual.•To support regulatory submission by execution of different analytical work, preparation and review of analytical documents within required timelines.•To prepare databases and trend chart of OOS, OOT and Analytical Incidents. •Initiate, and follow through with actions required to close Change Controls.•To update supervisor / head of QC immediately whenever any OOS /OOT/Deviation/Non-Compliance is noticed. Show less