Job Description

Job profile - Senior Executive QA (Candidates from - Medical Device Pharma Industry)
Conducting ISO 13485 audits

Location - Church-gate - Mumbai

Offered CTC 13 LAKS PER ANNUM (

Job profile - Senior Executive QA (Candidates from - Medical Device Industry only) Conducting ISO 13485 audits

Drop resume on - 8450934648

Email ID: kmasne88@gmail.com

Masters / Bachelors in Biotechnology / Biochemistry.

At least 5 years working experience. Worked in Medical Device Industry.

Good knowledge of English language, both oral and written.

Ability to work in a team

Job Objective

To ensure that the products meet SST CLIENT quality standards, ensure timely approval of SST CLIENT products

Assist the Managers in QA India team in different QA matters in order to ensure that the products meet SST CLIENT quality standards.

JD:

Reporting lines

The Senior Executive QA reports to the Manager Quality Affairs.

1. Product Approval (Medical Supplies)

Assess dossiers for product approval within applicable deadlines - Create items in ERP system and ensure timely updations and maintenance.

Create artworks for approved products and ensure timely updations and maintenance. - Handle Purchase queries within applicable deadlines -

Communication with suppliers regarding requested items, developments in dossier requirements and registration overviews

Reviewing product requirements by Sales/ Customer and liaising with purchase(sourcing) to get right type of product. - Maintaining overviews on product approvals.

2. Registration and Tenders

Registration as per planning - basic SST CLIENT dossiers - review and request for deficient documents within 15 days of the receipt of the fabricant dossier -

country dossiers, questionnaires, query replies, renewals, fiche techniques, planning and submission of variations - as per deadlines given -

raising payment requests and maintaining an overview of payments - on going, as and when applicable

Communication with suppliers regarding requested items, developments in dossier requirements and registration overviews (within 24 hours)

Performing trend analysis as planned

Ensure timely updation of IWs for different countries as per the latest registration guidelines, within 5 working days.

Conduct and maintain records on samples requested and dispatched for registration.(within 24 hours)

Arranging for dispatches of dossiers and samples for registration - as per the deadlines given

3. Audits

Conducting ISO 13485 audits

Conducting verification audits

Conducting transit warehouse audits

4. Assisting Managers in QA India team in QA matters

Proactively assist the Head, Manager and Unit Managers in resolving certain QA matters -

Effectively coordinating and communicating with different departments and other team members in order to ensure clarity in QA matters.

Regards

Job Types: Full-time, Permanent

Pay: ₹90,000.00 - ₹110,000.00 per month

Benefits:

Cell phone reimbursement Health insurance Internet reimbursement Leave encashment Life insurance Paid sick time Provident Fund
Work Location: In person