Job Description

a. Preparation/Review of annual product quality review of all finished/sealable products, approved vendor list for RM/PM as per vendor qualification procedure, Master Formula Card/Master Product Control Record as per procedure, Validation (Process, Cleaning) Protocol & Report, Dirty & Clean Hold Time Study Protocol & Report.

b. Review & approval of executed batch manufacturing records for dispatch, of equipment/utility/system qualification documents like DQ/ IQ/OQ/PQ, calibration of measuring and monitoring devices like PG/ VG/ TI etc.

c. Responsible for release of finished product batches and approval of COAs for dispatch of material. Review & Release of Finished Product in ERP System.

d. Handling of QMS activities like Change Control, Deviation, Return Goods, Market complaints, OOS, OOT, Incidents etc.

e. Responsible for customer support like preparation of required documents, filling and sharing of vendor questionnaire along with documents. co-ordinate and conduct customer /regulatory audit and provide CAPA based on the outcomes of the observations.

f. Preparation/Review of Standard Operating Procedure of Quality Assurance Department, also responsible for review and approval of other department SOPs.

g. Preparation, Review and approval of Site Master File & Validation Master Plan as per procedure and quality risk assessment related to product, system etc.

h. Conducting/provide the training for SOP, Guidelines, other activities as per requirement.

a. Masters in Science (Chemistry)

b. Minimum 5-7 years of work experience from pharma, preferably in quality assurance environment

c. Knowledge and Experience in US FDA approval, GMP compliance.

Job Type: Full-time

Pay: ?149,280.02 - ?544,384.36 per year

Benefits:

Provident Fund
Ability to commute/relocate:

Vapi, Gujarat: Reliably commute or planning to relocate before starting work (Preferred)
Application Question(s):

Have you worked in API ? Total Experience ? Current CTC ? Expected CTC ? Notice Period Can you relocate to vapi ?
Education:

Master's (Preferred)
Experience:

APIs: 4 years (Required)
Work Location: In person