Qc Manager

Role & responsibilities

• Daily Planning, Execution and tracking of the batch release like DS, DP, IPQC & Protocol samples in quality control department.
• Review and closure of all applicable QMS documents, Change Control, CAPA, Incident, Deviations, OOS, OOT and compliance investigations.
• To Manage & responsible for Planning for analysis and tracking of batches release DS, DP, IPQC & Protocol based samples.
• Should have strong knowledge on operational of the instrument like RT PCR, HCP, HCD, SDS PAGE, WBT, IEF, CZE, and Maurice & Protein testing by UV Spectrophotometers in Quality Control Department.
• To prepare, review and approve the documents like SOP, STP, Specification, Protocol, MVP, MVR, DRS, and MOA, Log book, deviation, change control, CAPA, Excel sheet validation. COA and other GMP documents.
•  To be involved at the time of LIR, OOS, OOT and investigation studies, Change Control, CAPA, Deviation, method transfer / validation activities, as and when required.
• To manage the internal as well as external audit and Lab compliance activity.
•  Execution of gap analysis of QC system and effective implementation of cGMP and regulatory requirements.
• Preparation, review and revision of documents as and when required. To verify calibration/ verification/ qualification/ cleaning/ monitoring activities of various QC instruments/ equipments as per schedule.
• To manage and review of the documents like: Method Transfer, Method Validation and responsible for the tracking of the activity till completion of the project.
•  To provide direction to the subordinates in the labs and ensure defined quality system / GMP norms are being followed during analysis and ensure state of compliance in laboratory.
• Responsible for general work place cleanliness, proper equipment management and adherence to all approved SOPs and GMP procedures.
• Responsible for timeline completion and resolution of regulatory, CFT, Client, RTD query and responses.
• Responsible for batch release in SAP and LIMS and approval of chemical reagent in LIMS. Also results to be updated in SAP.
• Responsible for review of the logbooks, Data recording sheet, STP, Specifications, instrument labels, and pipettes calibration data.
• Responsible for cleaning of the refrigerator and samples discarding/Antibody discarding time to time.
• Candidates should have strong communication skill in English.