QA SME (Chemist)

Experience: 7 to 8 years

Location: Ahmedabad, Gujarat, India

Skills: GMP practices, Valuable documentation control practices (GDCP), Qualification of Software's, PQ through CSVMP, Regulatory audits, TIMS, Documentum, trackwise, SAP

Name : Isha Naik
BU : Quality Assurance
Place : ZLL-SEZ Oncology Injectable, SEZ, Matoda, Ahmedabad.
Email Id : [email protected]
Basic Details:
Position : 60047732
Designation : Senior Executive
Reports to : Doc-Cell Section Head
Department : Quality Assurance
Location : ZLL-SEZ Oncology Injectable (Alidac)
No of Posts : 1
Role : Senior Executive Neev
Level : 1
Details : Replacement Position
code : 60047732
Position Name : QA SME (Chemist)
Key Job Description:
1. To Manage whole training programme (e.g. To co-ordinate with trainers and trainees to run training programme smoothly at site).
2. To handle induction training programme.
3. To maintain all training records and ensure all the trainings at site shall be conducted as per timeline followed by GMP practices.
4. To perform issuance of all the GMP documents by making them master,



effective and distributed as per GMP practices in controlled manner.
5. To manage procurement and to maintain stock of all log books/stationary and all other items through SAP by preparing PR/PO in system.
6. To ensure adherence to Good documentation control practices (GDCP) during all cGMP activities to maintain data integrity and Traceability.
7. To have knowledge of Qualification of Software's for atomization and digitalization. (atleast basic knowledge of PQ through CSVMP).
8. To have knowledge of documents archival, retrieval and destruction procedure.
9. Personnel should have exposure to Regulatory audits.
10. Personnel will be more preferable having experience to run softwares like TIMS (Training information management system), Documentum, trackwise, SAP (for procurement) etc.
Education :
Qualification : B.Sc/B.pharm
Years of Experience : 7 to 8 Years
Experience / Exposure in: Issuance, Training, Procurement (Logbook Stock) Qualification of GDP, DI Documentation Cell
Mail your CVs to: [email protected]

📌 QA SME (Chemist) (Ahmedabad)
🏢 Zydus Lifesciences
📍 Ahmedabad