To perform QC activities in order to ensure quality of products and services and
maintain related documentation to adhere to quality operations and regulatory
requirements.
All above activity shall be done living Group’s Values and Code of Ethics.
REQUIREMENTS
Education / Experience
POST GRADUATE IN CHEMISTRY/PHARMACY
Experience: 3-5 years in a Quality Control/Analysis laboratory in a cGMP/ISO
environment, with exposure to method development and validation activities
Technical skills &
Competencies / Language
* Technical competence
* Leadership skills
* Analytical ability
* Planning ability
* Communication skills
* Problem solving
* Team Building
KEY ACCOUNTABILITIES
1.ANALYSIS AND APPROVAL
Sampling, analysis and ascertaining quality of raw materials, packaging
material, intermediates, In-process samples and API for Chemistry Ankleshwar.
Testing of the method validation samples and process validation samples and
cleaning validation.
Perform analysis and documentation of API finished product
stability study as per stability study protocol. Coordinating with Production,
Stores and QCAA for Approval / Rejection of raw materials/finished product.
Validation and verification of analytical procedures as per requirement.
Reporting OOS / OOT results and deviations. Maintaining retained samples as per
standard procedure. Assisting in investigation of customer complaint. Testing of
current samples (Vendor approval) Training of subordinates Give required suggestion
for corrective actions and to plan effective preventive actions for the up
gradation of the quality system. To ensure proper maintenance of the stability
samples and their management. Disposal of waste according to the approved
procedures. Continual reduction in the waste generation and effluent management.
Co-ordination with microbiology lab (Pharmaceuticals) for microbial analysis of
products and utilities.