Job Summary:

　　This position shall be responsible for Oversight and Monitoring of cGMP compliance as per Sun Pharma Quality Standards for Quality Control Laboratory at Drug Substance Manufacturing site.

　　Essential Job Functions:

　　To ensure compliance and ATR in Quality Control Lab.

　　To provide support in identification of RCA and CAPA.

　　To ensure implementation and effectiveness of CAPA.

　　Randomly review of analytical reports for compliance point of view.

　　Reviewing OOS, OOT, Lab event, and deviation investigation related to QC.

　　Preparation of OOS, OOT and Lab event trend.

　　Lab Compliance (Procedural compliance verification, Lab round and verification of online QC activities).

　　Proactively assess quality issues at site and ensure compliance to the defined procedures and regulatory requirements in Quality Control laboratory at site.

　　Ensure that the Labs meet the requirements of GLP at all times, the quality systems are maintained, equipment are routinely checked and results recorded of correct function, etc.

　　Ensure consistency QC lab operations and drive continuous improvements in laboratory performance.

　　Ensure compliance to cGMP/cGLP and applicable safety standards in QC Labs.

　　Performs all work in support of our Corporate Values of Pride, Accountability, Integrity and Diligence. Performs all work in accordance with all established regulatory and compliance and safety requirements.

　　Preparation and Review of Standard Operating Procedure as per EDMS application.

　　To perform the activity as per the user roles defined in the electronic software. (EDMS, LIMS and Track wise system).

　　Requirements and Qualifications:

　　A minimum of a bachelors degree in Chemistry, Pharmacy or relevant scientific field is required. A graduate degree in a related discipline would be an asset. A minimum 1 years of experience in a pharmaceutical quality management system is required. A good knowledge of cGMPs in both domestic and international regulatory environments is required and Sun Pharma Global Quality Policy\Standards at site.

　　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.