Website Stride ltd
Post Name: Executive – Quality Assurance (CPV)
Key skills:
Documentation Compliance:
i. Review the logbooks for online entries and its correctness.
ii. Ensure timely revisions and availability of current SOPs/WIs.
iii. Ensure SOPs/WIs are in line with the practice and revision there of if required
iv. Facilitate timely completion & effective implementation of QMS system deviation.
v. Verification of critical equipments generated printout (process data) like assay calculation, LOD, recipe during execution of batches.
vi. Ensure batch records are disposed off in time.
vii. Improvements of RFT in Shop Floor.
viii. Review of E-BMR & E-Logbook
Operations Review:
i. Follow up for WIP and under hold batches and ensure disposition actions in case of destruction of rejected batches.
ii. Study yield, quality trends, incidents, understand product behavior and effectiveness of the manufacturing and formulation process and suggest improvement.
Training:
i. Training through self-study for all the related SOPs/WIs.
ii. Personal update through self-study of GMP trends and goal sheets.
iii. Study yield, quality trends, incidents, understand product behavior and effectiveness of the manufacturing and formulation process and suggest improvement.|
iv. Training through self-study/ classroom training/OJT for all the related SOPs.
Continued Process Verification:
i) Preparation of Continued Process Verification reports for the products manufactured to discover the existence and level of variability in the process and understand the sources of process variability and control the variability in the process in a proactive manner.
ii) Compilation of Critical process parameters, Critical Quality Attributes, Critical Material Attributes, yields, Stability performance, Product deviation rate, confirmed market complaints rate, batch Rejections, Cycle time and interruptions in critical processes.
iii) Trending of Critical process parameters, Critical Quality Attributes, and Critical Material Attributes.
iv) Statistical evaluation by using of relevant software applications.
Quality Management System:
i) Preparation of Elemental Impurity risk assessment & Nitrosamine impurity risk assessment in product.
ii) Conduct risk assessments for elemental impurities (e.g., heavy metals, arsenic) and nitrosamine impurities in pharmaceutical products.
iii) Evaluate raw materials, manufacturing processes, and packaging components for potential sources of impurities.
iv) Apply ICH Q3D and Q3E guidelines, as well as FDA and EMA regulations, to risk assessments.
v) Develop and implement control strategies to mitigate impurity risks, including raw material testing, process modifications, and analytical method development.
vi) Collaborate with cross-functional teams, including manufacturing, quality, and research and development.
vii)Author and review technical reports, risk assessments, and other documents related to impurities control.
viii) Stay up-to-date with regulatory changes and industry trends related to impurities control.
ix) Ensure SOPs/WIs are in line with the practice and revision there of if required.
