Sr. Executive-QA

1. Our client is Europe-based and has a requirement for the Mumbai location. 20 Years old organization

Job profile

1. Senior Executive QA
2. Location Church-gate – Mumbai
3. Offered CTC 13 LAKS PER ANNUM
4. Masters / Bachelors in Biotechnology / Biochemistry / Mpharm / Bpharm.
5. At least 5 years working experience related to Medical supplies.
6. Good knowledge of English language, both oral and written.
7. Ability to work in a team

Job Objective

1. Product Approval : To ensure that the products meet SST Client quality standards, ensure timely approval of SST CLIENT products
2. Quality Affairs : Assist the Managers in QA India team in different QA matters in order to ensure that the products meet SST CLIENT quality standards.

Reporting lines

1. The Senior Executive QA reports to the Manager Quality Affairs.
2. Product Approval (Medical Supplies)
3. Assess dossiers for product approval within applicable deadlines - Create items in ERP system and ensure timely updations and maintenance.
4. Create artworks for approved products and ensure timely updations and maintenance. - Handle Purchase queries within applicable deadlines –
5. Communication with suppliers regarding requested items, developments in dossier requirements and registration overviews
6. Reviewing product requirements by Sales/ Customer and liaising with purchase(sourcing) to get right type of product. - Maintaining overviews on product approvals.

1. Registration and Tenders

1. Registration as per planning - basic SST CLIENT dossiers - review and request for deficient documents within 15 days of the receipt of the fabricant dossier –
2. country dossiers, questionnaires, query replies, renewals, fiche techniques, planning and submission of variations - as per deadlines given –
3. raising payment requests and maintaining an overview of payments - on going, as and when applicable
4. Communication with suppliers regarding requested items, developments in dossier requirements and registration overviews (within 24 hours)
5. Performing trend analysis as planned
6. Ensure timely updation of IWs for different countries as per the latest registration guidelines, within 5 working days.
7. Conduct and maintain records on samples requested and dispatched for registration.(within 24 hours)
8. Arranging for dispatches of dossiers and samples for registration - as per the deadlines given

2. Audits

1. Conducting ISO 13485 audits
2. Conducting verification audits
3. Conducting transit warehouse audits

3. Assisting Managers in QA India team in QA matters

1. Proactively assist the Head, Manager and Unit Managers in resolving certain QA matters –
2. Effectively coordinating and communicating with different departments and other team members in order to ensure clarity in QA matters.