Sun Pharmaceuticals, Inc is Looking for Executive QA of QC at India Full Time

• Review of Raw Material/Packaging Material/Stability/Microbiology/Cleaning Method Validation/Validation/Finished Product Analytical data, Certificate of Analysis & related documents.

• Review of Exhibit Stability Protocols.

• Preparation and review of Validation /Pre-Validation /Commercial/Annual addition batch/Thermal Excursion/additional study stability protocol.

• Review of In-Vitro/CU and Dissolution sheets.

• Review of Analytical Method Transfer documents.

• Participation in handling of OOS, OOT, Investigation and Deviations related to Quality Control.

• Review of weekly and monthly software verification reports of Empower 3

• Periodic verification of application software on computer systems, associated with laboratory instruments with system administrator.

• Review of lab instruments Calibration/Preventive maintenance data.

• Review and submission of analytical data to site regulatory affairs.

• To provide the response of Regulatory Affairs and Office of Data Reliability queries.

• Review of Change Control request, Specification, Standard Test Procedure and SOP in Documentum Compliance Manager System.

• To made effective various documents in Documentum Compliance Manager System.

• To ensure compliance and all time readiness in Quality Control Laboratory

• Work with Quality control management team to prepare for host internal and external auditors. Assists laboratory management team to ensure timely closure of audit observations.

• Provide appropriate training and development to support staff to meet their respective job responsibility.

• To conduct laboratory visit, to oversee the lab compliance and to rectify the gaps identified.

• Execution of applicable SAP transactions as per responsibilities identifies.

• To perform Gap Assessment for Pharmacopeial Changes as per USP and Ph. Eur. and to ensure compliance as per SOP.

• 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

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.