Job Description
Role & Responsibilities - QC BAS
Responsible for periodic training management related to quality, GMP, regulatory aspects to Bioassay section personnel's and evaluation of effectiveness.
Responsible for compliance to Internal, External & statutory compliances as per quality policy of Enzene, pharmacopoeia guidelines and other regulated guidelines related to Bioassay section.
Responsible for the Periodic assessments / Audits to identify gaps/Improvement opportunities for strengthening the quality & regulatory compliance. Prepare remediation/mitigation plan (CAPA) and execution in a timely manner by coordinating with cross functional to uplift the level of compliance related to Bioassay section.
Responsible for review of COA (Certificate of analysis).
Responsible for review of documentation related to Bioassay section such as SOP's, Specifications, STP's, TDS, Reports of IRS, Analyst qualification etc.
Responsible for Review of Protocols, Qualifications and Reports related to Bioassay section.
Responsible for investigations related to OOS, OOT and deviations and to recommend appropriate CAPA, change controls related to Bioassay
Responsible for review of calibration and validation documents of instruments and equipment's related to Bioassay section.
Responsible for review of Bioassay data.
Ensure compliance and adherence to data integrity.
Responsible for review and approval of stability protocols, stability study reports, stability trends, stability calendar, stability matrix related to Bioassay section.
Responsible for the review and approval of calibration matrix and planner related with Bioassay section.
Responsible for the online closures of QMS elements (Change control, CAPA, Deviation, OOS, OOT and Laboratory incidents) related to Bioassay section.
Responsible for the preparation and review of audit responses (Internal and External) related to Bioassay section.
Responsible for the review of new software implementation and related documents with Bioassay section.
Responsible for work assigned by immediate supervisor.
Responsible for the work carried out in the absence designee.
Qualification : MSc
Experience : 12 to 14 years
