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sun pharma industries
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QE- Manager

QE- Manager

sun pharma industries

4 - 9 years

6 - 11 Lacs

mumbai

Posted:10 hours ago| Platform:

Apply

Skills Required

procurement global operations computer system validation pharmacy risk assessment indenting packaging gmp operations process equipment

Work Mode

Work from Office

Job Type

Full Time

Job Description

Job Title:

Projects & Engineering - QE

Business Unit:

Sun Global Operations

Job Grade

G10 - Manager 1

Location :

New green field site (Pithampur Indore)

At Sun Pharma, we commit to helping you

Create your own sunshine

by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.

Are You Ready to Create Your Own Sunshine

As you enter the Sun Pharma world, you ll find yourself becoming Better every day through continuous progress. Exhibit self-drive as you Take charge and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we Thrive together and support each other s journeys.

Key responsibilities:

Expertise in qualification of below process and equipment s :

To aware about the process like vial washing, depyrogenation, filtration, filling, manufacturing, lyophilizer, component washing and sterilization, terminal sterilization, isolators, CIP SIP skid, leak test, X ray inspection, VHP, clean utility like steam, compressed air, PW and WFI generation system, AHU, FFM,
To handle the designing and qualification activity of process equipment s like vial washing, tunnel sterilizer, filling machine, capping machine, Lyophilizer loading and unloading system, Lyophilizer, filtration skid, and isolators, VHP passbox, manufacturing skid, suspension manufacturing skid, CIP SIP skid for manufacturing and filtration equipment s, dispensing isolators, manufacturing isolators, pH meter, DO meter, integrity tester, Autoclave, Terminal sterilizer, ultrasonication machine, GMP washer, external washing machine, leak test and X ray inspection machine, packing equipment s etc.
To handle the designing and qualification activity of Utility like Pure steam generation and distribution system, Purified water and WFI generation and distribution system, Nitrogen and compressed air generation and distribution system, AHU, FFM, LAF, area, cold storage etc.

To handle indenting to procurement of accessories and equipment s required for qualification activity of above equipment s and area.
To handle preparation, review and execution of qualification protocol of new equipment like, User requirement specification, Design qualification, Installation qualification, operational qualification, performance qualification and Computer system validation and qualification.
To prepare schedule for qualification activity, calibration activity, updation of status label of qualification activity etc.
To prepare and execution of schedule requalification protocol of equipment s and utility.
To prepare new standard operating procedure for qualification activity and also review SOP of process equipment s.
To handle the QMS documents like change control, CAPA, risk assessment, deviation etc.
To handle communication with vendor and procurement team on design parts of new equipment s.
To ensure compliance to cGMP and documentation for various qualification activities.
Issuance, retrieval and storage of qualification documents.
Ensure proper planning and execution of the qualification activity in accordance with the plan and allocation of man power.
Exposure of regulatory auditors like USFDA, EU, ANVISA, CANADA etc.

Travel Estimate

As required

Job Requirements

Educational Qualification

B. Pharmacy, M. Pharmacy

Experience

Tenure

: 5 to 10 Y Years of experience in relevant field in Pharmaceutical Industry

Disclaimer:

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QE- Manager

Experience & Salary

Skills Required

Work Mode

Job Type

Job Description

Job Title:

Business Unit:

Job Grade

G10 - Manager 1

Location :

New green field site (Pithampur Indore)

Create your own sunshine

Key responsibilities:

Travel Estimate

Job Requirements

Educational Qualification

B. Pharmacy, M. Pharmacy

Experience

Disclaimer:

More Jobs at sun pharma industries

QE- Manager

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