Responsibilities
- Responsible for overall Quality control function of General block and Hormone block.
- To ensure the monitoring of RM, PM, In-process (Compression, Blend, Coating, and Filled Capsule), Bulk product, Finished Product, Stability, Micro and Process Validation samples analysis plan for their timely sampling, analysis and release.
- To ensure proper destruction of the left over sample.
- To ensure cGLP/ cGMP/ 21 CFR part 11 compliance in the laboratory.
- Co-ordination with R&D/outside labs from where product is transferred at site.
- Co-ordination with the customers for easy transfer of the projects.
- To approve the job description and assign the job to all QC team.
- To ensure that all the samples work sheets shall be controlled/ taken from LIMS.
- To Review of Finished product specifications, standard test procedures and work sheets in LIMS.
- To monitoring the samples to be sent to external labs for testing in which testing facility is not available.
- To coordinate with dispatch team and ensure to prioritize the analysis as per dispatch exigencies, and release the batches within stipulated time frame as per dispatch plan.
- To ensure the technical review, guidance and timely completion of Investigations e.g. OOS and OOT, Deviations, incidents and CAPA within stipulated time frame.
- To ensure the availability of current versions of the Specifications, Standard test procedures & work sheets are available in Documentation section.
- Drive continual improvement in business process/ operations with focus on business plan/ strategies.
- To identify the resources for QC function and ensure optimum utilization of resources.
- To review the risk assessment related to quality control.
- To impart the necessary trainings time to time to enhance the competencies and skill development.
Qualificatio
nsMsc. / M. Pharma in Chemist
ry
Experie
nce20+ Years experience in QC and Min 5 years experience as Head
QC
