General Manager - Quality Control, Baddi

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