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Sun Pharmaceuticals, Inc Senior Executive in India

CMC - QA (Analytical Development, Gurugram)

  • To review the Method Validation / Method verification/Method Equivalency / Method Transfer data for its adequacy, accuracy and completeness accordingly regulatory and business requirement for intermediate, drug substances, drug products (i.e. Solid Oral Tab / Cap / PFOS etc.).

  • To review analytical method development documents / data in order to achieve robust method development to decrease method failure at plant.

  • To review and approve Analytical Method Transfer documents for manufacturing site.

  • To support on pharmacopoeia updates and new regulations for Analytical Development Department in order to ensure continual improvement in the quality system.

  • To review QMS documents i.e. change control, deviation, equipment qualification (IQ/OQ/PQ), OOS, OOT, CAPA for cGxP compliance for Analytical Development.

  • To review Standard Test Procedure, SOP, Guideline for Analytical Development.

  • To review Product Development report for the analytical accuracy.

  • To conduct audit of Analytical Development

  • Must have strong interpersonal and communication (written and spoken English) skills.

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.