Experience Inc. Jobs

Position: Sr Executive / Manager Quality Assurance

Grade: G11B / G11A

No. of Position: 1 No.

Job Location: Ahmednagar

Qualification: B.E. (Chemical) / M.Sc. (Chemistry)

Experience: 8 to 10 yrs experience in B.E. (Chemical) / M.Sc. (Chemistry) of API manufacturing plant

Job Profile

• To participate in various investigation as applicable. To review and approve assessment report, investigation reports for change control, OOS, incident, deviation, market complaint and risk assessment.

• Responsible for imparting of trainings to Quality and cross functional teams.

• Review and approve of GMP documents related to activities like Batch release COA, BMR, Annual product Quality Review.

• Review, approve transitions in softwares like, EDMS, Track wise, Metis, SAP, HANA and SAP.

• Review and approval of SOP, protocol / report of process validation, cleaning validation, equipment qualification, AHU/HVAC qualification, water system validation, area qualification, temperature mapping, various layouts and software validation protocol/reports, vendor qualification documents, evaluation of supply for quality (Q Score) and vendor annual risk assessment, VMP, PPQMP and CVMP as and when required.

• To follow safety and use of required personal protective equipment during day to day activities.

• To conduct new Employee induction training / cGMP training / SOP training

• To carry out any other responsibility assigned from time to time orally or in writing by reporting authority by ensuring completion of required tracking.

• Ensure the quality policies, standards and procedures for implemented and adhered at site.

• Review and approve the documents as per quality procedures.

• Review / support to draft response of internal / external audit observations for systems and ensure its compliance.

• Ensure the QMS (Deviations, Change Control, CAPA, incidences etc.) related to systems are closed in timely manner.

• Work in partnership with the site cross functions and corporate functions for implementation of new initiatives for systems.

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.