Designation: QA Ra Chemist - Surat, India - Actide International
Description
Description:
Job Profile for QA/
RA :
4-5 Years of Experience
- Experience to prepare and review the documentation required for the ISO 9001:2015,
IMDR 2017.
- Knowledge and preparing documents such as Quality Manual, Site Master File, SOP's,
Review Meeting, pdate Harmonized Standards, Internal Quality Audits, Audit calendar,
Audit plan, List of Quality Records, Distribution of documents, PMS and PMCF.
- Preparing and reviewing the Technical Master File (TMF) and Design File for CE
- Exposure of various countries regulatory such as a African Countires, Latin America,
- Reviewed the Calibration and Process Validation activity; authorize to maintain DQ,
- Preparing Annual product review report.
- Prepare checklist for the warehouse and vendor audit as per the ISO 13485 standard.
- Submission of license variations and renewals within strict deadlines;
- Prepare the specifications of testing of raw material, In-process Material, Packing
- Monitor and trend key quality objectives of all departments.
- Maintenance of IQA documents with its report and evidence.
- Knowledge and prepare about MRM (Management Review Meeting)
- Maintaining External Audit Documents and compiling its evidence.
- Reviewing and maintaining Artwork, Pack insert and labels.
- Maintain and update Post marketing surveillance reports. Knowledge about
- Coordinate with R&D and manufacturing to develop validation protocol for production
- Review all data prior to submission to regulatory agencies, focusing on CE regulatory
- Support team leader to respond to queries of regulatory authorities and external audits.
Job Types:
Full-time, Regular / Permanent
Salary:
₹100, ₹500,000.00 per year
Schedule:
- Day shift
Ability to commute/relocate:
- Surat, Gujarat: Reliably commute or planning to relocate before starting work (required)
Education:
- Bachelor's (preferred)
Experience:
- total work: 1 year (preferred)
Speak with the employer
- 91-XXXXXXXXXX
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