General Manager Quality Control

Role & 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.

Preferred candidate profile