Manager - 1 Fresher's job

Job Responsibilities:

1) This position is accountable for developing procedures / system and for assuring compliance to them by the R&D function.

2) Ensure Compliant Development of New Drug Application, New Drug Delivery system, Drug Products formulations and technology transfers to the manufacturer organisation.

3) To review and approve Method Development/Method Validation / Method verification/Method Equivalency / Method Transfer data for its adequacy, accuracy and completeness as per regulatory and business requirement for intermediate, drug substances, drug products (i.e. Solid oral Tab / Cap / PFOS etc.) in order to achieve robust method development and to decrease method failure at site.

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

5) To review and approve QMS documents i.e. change control, deviation, equipment qualification (IQ/OQ/PQ), OOS, OOT, CAPA and conducting audit for cGxP compliance.

6) To draft, review guidelines /SOPs/Protocols/Reports.

7) Assure that formulation process packages are reviewed adequately within the team to verify scientific rigor, adequacy, and completeness (Pre formulation data, Product quality risk assessment, stability data and trend interpretation, RLD data, suitability of test with reference product, product quality specification etc).

8) Ensure the Compliant Development of product development activities related to New Drug Application, New Drug Delivery system, Drug Products formulations and technology transfers and their method transfers to the manufacturer organisation.

9) Review of scale up data, process robustness and statistical evaluation, technical evaluation for adequacy w.r.t. concluding trials and changes proposed.

10) To review and assess data based on QBD based approach. To ensure product development data supports to robust product quality through review of documents / scientific knowledge.

11) To coordinate with cross functional team e.g. Analytical Development, Site QA/QC, Project management, Regulatory for successful transfer and filling of product.

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

13) Must have excellent negotiation and interpersonal skills and ability to communicate effectively with all levels of the organization and external stakeholders.

14) Work effectively in an international multicultural matrix organization is strongly preferred.

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Sun Pharmaceutical Industries Limited is an Indian multinational pharmaceutical company headquartered in Mumbai, that manufactures and sells pharmaceutical formulations and active pharmaceutical ingredients in more than 100 countries across the globe.