Encube Ethicals Pvt. Ltd multiple opening in Quality Assurance Department for the Post of “Executive/Sr. Officer/Officer in QA – TT(QA) Training & CSV
Greeting from Encube Ethicals Pvt. Ltd.!
We are looking for an aspirants in Quality Assurance Department for the Post of “Executive/Sr. Officer/Officer – QA”.
3 vacancies – TT-QA, Training & CSV
1. Executive/Sr. Officer – QA (Technology Transfer)
Qualification: B Pharm / M Pharm
Experience: 04 – 06 years in TT – QA only
Job Description:
– Monitor & track TT activities pertaining new products from R&D or other sites as per timeline.
– Co-ordinate with Customer/Client, Production, QC, R&D and QA for completion & availability of necessary documents for product transfer.
– Evaluate gap analysis, risk assessment before start of site transfer activities for site readiness.
– Monitor pre-exhibit, Exhibit, validation batches manufacturing and timely submission of data of Exhibit batches to RA for submission.
2. Sr. Officer – QA (Training)
Qualification: B Pharm / M Pharm
Experience: 03 – 05 years in Training only.
Job Description:
– Prepare training calendar & modules.
– Arrange trainings & maintain documents (employee matrix) & training records for Instructor Led Course.
– Administer & review of Audit Trails for Compliance Wire Software.
– Impart defined training to individuals or groups of employees. & guide the new entrants for On-the-Job Training.
– Enquiries relating to training and development.
3. Officer – QA (CSV)
Qualification: B Pharm / B E
Experience: 01 – 03 years in CSV only.
Job Description:
– Shall have Knowledge of SCADA, PLC, HMI and integrated application systems.
– Knowledge of Pas-X from Werum Software, MES exposure/hands on experience is an added advantage.
– Validation and qualification of various software like SAP or ERP, BMS System, PLC, HMI, etc.
– IT Compliances, CSV related guidelines, GAMP guidelines, 21 CFR, etc.
– Projects implementations of SCADA, DMS, IOT Projects, project developments and reviews.
Those candidates who matches above mentioned criteria and are interested can share their resume on [email protected]
Kindly mention the subject of the mail as “Application for QA Dept. – TT / Training / CSV”
