Sashank Mishra

To obtain a challenging position that will allow me to showcase my skills and knowledge to succeed in the field of pharmaceuticals.

Sr. QUALITY ASSURANCE OFFICER - BDH INDUSTRIES LTD

(2023-08-01)

IPQA and QMS job responsibilities

• To Prepare & Reviewing of SOP.
• Acceptance of Raw Materials for manufacturing.
• Calibration, Verification and Validation of Balance and Equipment/Instrument.
• Monitoring Production process & Line Clearance at the start of each steps.
• Ensuring Compliance of SOP's & In-process Testing.
• Dispatch Checking & Providing release slip for outsourcing to market.
• Assuring High Standard of General & Anticancer Tablets, Capsules, Injection, General & Sterile Creams/Ointments/Lotions and Internal & External ELixir.
• Validation and Re-Validation of the Process Validation, Analytical Method Validation, Finished Product Specification, Standard Testing Procedure, APQR & Stability Studies.
• To prepare and review protocols, data integrity (ALCOA++), RCA, audit handling, MOM, and MRM.
• To review and approve qualification documents (IQ, OQ, PQ) and monitor the qualification, re-qualification and validation of instruments/equipment's.
• To Fill & manage the Change Control & Deviation.
• To assist the RA team with dossier preparation (CTD Triangle) and gap bridging compliance.
• To show interest in doing new task assignment as CAPA, ISO, ICH, WHO & cGMP Guidelines, DMF, AUDIT of Plant Premises and Gap Analysis Matrix.

Bachelor of B Pharmacy - Pharmacy - VIVA INSTITUTE OF B PHARMACY (2019-01-01 - 2023-01-01)

12th Pass - SHRI . TB BHATIA COLLEGE OF SCIENCE (2019-01-01 - 2017-01-01)

10th Pass - SWAMI VIVEKANAND INTERNATIONAL SCHOOL (2001-01-01 - 2017-01-01)