Position: Manager / Sr Manager Quality Control Grade: G10 / G9B No. of Position: 1 No. Job Location: Ahmednagar Qualification: M.Sc. (Chemistry) Experience: 10 to 15 yrs experience in Quality Control dept of API manufacturing plant **Job Profile** + Overall responsibility of Onco & Peptide lab of QC function in various audits. + To ensure sampling packing of Intermediates / Finished as per approved standard operating procedures. + Ensure complete analysis of Intermediates / Finish / In-process / Process Validation / Decontamination samples within stipulated timeframes as per standard timeline, specification and method analysis. + To ensure stability study sampling, analysis, review as per approved protocol, ATP & SOP approve the stability study reports. + To review the analytical method validation, method transfer, regulatory submission related documents, working reference standard procurements. + To co-ordinate self-inspection (internal audit) and its compliance. + To QC approve the lab event/ out of specification / out of trend/ out of calibration / CAPA / Change Control / deviation. + Ensure trend of Onco & Peptide lab errors and effective CAPA implementation. + To monitor the compliance with the requirements of good manufacturing practice and good laboratory practice. + To participate in management reviews of process performance, product quality and of the quality management, system and advocating continual improvement + To ensure a timely and effective communication and escalation process exists to raise quality issues to appropriate levels of management. + To conduct training program and ensure it effectiveness. + To ensure quality control GLP related activities are performed as per SOP for calibration, qualification of instrument and equipment. + To ensure laboratory safety. + To follow safety & use of required personal protective equipment during day to day activities. + Maintaining housekeeping at shop floor and reporting day to day activities to QC head and in absence, delegate change to second line manager. + To participate in laboratory in internal audits, customer audits, health authority inspections. We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.