Executive (Validation & Life Cycle Management)

• Feb 2022 - Present

My main activities regarding the current position are Cleaning Validation, Clean Equipment Hold Time Study, Dirty Equipment Hold Time Study, MACO Calculation, Worstcase Product Selection, Process understanding, Process Optimization, Manufacturing Site Transfer, Process Performance Qualification(PPQ), Continued Process Verification etc. Some other major responsibilities are: • Implementing pertinent procedure and instruction of the Quality Management system to ensure compliance to quality policy to the organization. • Establishment of validation and technology acceptance criteria and closing criteria by the technology transfer team of transmitting site. • To establish and implement validation life cycle program for manufacturing process, cleaning process and packaging validation and maintain GMP compliance at all times. • Preparation of process performance qualification as well as cleaning validation protocol and report etc. maintaining national and international regulatory requirements. • To complete the technology transfer and validation reports and follow up with implementation of recommendations. • Preparation of master formulation and packaging record, standard operating procedure, transfer protocol, gap analysis etc. required for transfer activity and throughout product life cycle. • Establish appropriate team roles and responsibilities for activities at the transferring site. • Timely exchange of information between transferring and receiving sites. • Facilitation of solving problems between transferring and receiving sites, if appropriate. • Preparation of batch manufacturing record (BMR) and batch packaging record (BPR) required for technology transfer activity and throughout product life cycle on required basis. • To comply with the requirements of Good Documentation Practice. • Collaboratively work with the other departments to ensure that the drug products meet standards of safety, potency, purity, uniformity and stability. Show less

Executive, QA(Validation)

• Jan 2020 - Jan 2022

Main Job Duties: • Author/Review/Execute process validation protocols and summary reports. • Perform validation testing and analyze data for validation documentation to determine acceptability, identify deviations and make appropriate notification. • Review/assess proposed changes to validated processes via CAPA, Change Control and Work Orders to identify requirements necessary to maintain validated status. • Production oversight during validation events. • Work to ensure validation documentation becomes part of the site’s GMP documentation database. • Review the manufacturing batch records before its issuing. • Lead in the development of a climate of quality and safety within the teams, by identifying and monitoring quality and safety standards. Show less

Inplant Trainee

• Apr 2017 - May 2017