Key Responsibilities

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.

Qualification and Experiences

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.

Competencies / Skills

a. Ability to work under pressure to meet specific timelines & targets

b. Well versed with industry specific products and its application

c. Strong analytical skills

d. strong leadership skills to coach and mentor the team, drive the business and develop newer strategies for developing market for the products

e. High Emotional Quotient

f. Strong communication and collaboration skill

g. Conflict resolution and problem resolution skills

Mandatory

a. Well versed with industry specific products and its applicatio

b. Robust analytical skills

Pay: ₹450,000.00 - ₹600,000.00 per year

Benefits:

- Leave encashment
- Paid sick time
- Provident Fund

Application Question(s):

- What is total experienc ?
- Relevant experience in api?
- what is your current CTC ?
- What is your expected CTC ?
- What is your notice period ?

Location:

- Vapi, Gujarat (Vapi) (Required)

Work Location: In person

📌 QA Executive (API Experience) (Vapi)
🏢 Vital Laboratories
📍 Vapi