Apotex
Designation : Manager
Function : QC
Functional Area : Quality Control
Job Role Summary : To ensure planning and monitoring of analytical activities, Instrument Calibration / Qualification, Investigations and Documentation as per the procedure in Quality control at  Apotex Research Pvt. Ltd.
Job Profile :
- Ensure the operations in Quality Control Laboratory as per the established standard procedure
- Ensure smooth functioning of all laboratory instruments in co-ordination with service engineers
- Conduct investigation for OOS / OOT results, and to identify assignable cause wherever applicable and to ensure timely completion of laboratory analytical investigations.
- Evaluation of Investigation, Deviations, CAPA and Change Control Records and approval as ‘Manager Approval’.
- Assist Quality group in various activities like data compilation for APQR, Training, Vendor development programme, Self-inspection and External audit programme.
- Assess, review, approval and ensure the timely completion of the changes in QC department as per established & approved change control procedure.
- Utilize your networks to attract and hire talent in a comprehensive, differentiated and consistent manner essential to our continued growth; then, onboard new employees by providing a consistent experience that reflects the values and commitments made to candidates during the hiring process.
Job Requirements :
- Minimum 16 to 20+ years of experience in GMP regulated Pharmaceutical industry.
- Knowledge on preparation and review of various documents like SOPs, formats, protocols, reports and analytical data etc.
- Knowledge on investigation and deviation report preparation.
- Having good command on trouble shooting on instrument and analysis.
- Having well versed knowledge on regulatory guidelines and thorough knowledge on cGMP activities.
- Effective command over verbal and written communication with good interpersonnel skills.
Proficient in MS office tools.
- Able to priortise the task, best in effective planning of work activities to meet the timelines.
Work / Job Experience : 16-20 Years
Type of Experience : Pharma QC, Instrument Calibration, Regulated GMP Environment
Academic Qualifications :
Minimum MSc /B Pharma or any equivalent degree.
