- 14 Jan 2019, 12:33
Job seeker with Post graduate of Pharmacy in Quality assurance and Diploma in Intellectual property rights currently working with Pfizer as Executive-Quality Assurance.
1 years 6 months experience in sterile manufacturing process, aseptic behavior and cGXP’s.
Company: Pfizer healthcare Pvt ltd: (Aug 2017-Jan 2019)
About 10 months experience (Aug 2017- June 2018) in manufacturing sterile injectable operations as production trainee executive. Demonstrated knowledge and experience in production compliance to comply with cGMP and GDP requirements.
Having fundamental knowledge of basic work routines and standards sufficient to operate within narrow boundaries.
Followed by 6 months experience in QA-Document optimization project as Executive-QA. Responsible for optimizing and simplifying all levels of documentation including SOPs, Batch Records etc. across IKKT. Process Mapping and identifying gaps in the current systems and processes.
Good exposure on implementation of GMP, GDP, PQS, ICH and sound knowledge of change management and data integrity.
Strong working knowledge of regulatory expectations.
Working knowledge of the drug development process, change management GxPs, 21 CFR Part11/EU Annex 11 and related regulations & guidelines.
(Aug 2017- June 2018) Production trainee executive to assist the manufacturing lines in shifts for operation and documentation by ascertaining aseptic practices.
Additionally to co-ordinate with supportive functions for ensuring smooth manufacturing operations.
To ensure compliance to systems and procedures.
(June 2018- Jan 2018) Executive in document optimization team for optimizing and simplifying all levels of documentation including SOPs, Batch Records etc. across Pfizer healthcare private ltd IKKT.
Business Process Lead for Aseptic Processing Area cleaning of delivering optimized documents for the sub area from process mapping, gap analysis and sop rewriting.
Responsible for optimizing and simplifying all levels of documentation including SOPs, Batch Records etc. across IKKT
Process Mapping and identifying gaps in the current systems and processes
Responsible for the correct and timely delivery of optimized documentation that comply with cGMP and GDP requirements within a department or quality system
Ensure end results are designed to mitigate Human Errors and reinforce Data Reliability
Understand end user requirements e.g. Shop floor employee requirements for Batch Record documentation.
Gain insight into the diverse processes in sterile injectables manufacturing and apply this knowledge in the creation of simplified instructions and procedures
Being the point of contact for the departments regarding documentation, to assess the impact on this if the working methods or standards change.