Quality Manager

Premas Biotech

3 - 7 years

5 - 8 Lacs

gurugram manesar

Posted:4 hours ago| Platform:

Apply

Skills Required

rp-hplc elisa sds-page sec-uplc dls electronic documentation systems empower/ chromeleon/openlab

Work Mode

Work from Office

Job Type

Full Time

Job Description

Role & responsibilities

Analytical Data Review:
Review and approve QC test data (HPLC/UPLC, qPCR, ELISA, SDS-PAGE, DLS, etc.) for biologics and recombinant proteins.
SOP & Protocol Preparation:
Draft, revise, and maintain SOPs for QC bioanalytical methods and instrument operation.
Prepare and review protocols/reports for method validation, stability studies, forced degradation, and other specialized studies.
Compliance & Documentation:
Ensure all documentation meets cGMP, GLP, ICH, and data integrity (ALCOA+) requirements.
Investigations & Change Control:
Lead/support OOS/OOT investigations, CAPA, and change-control processes individually.
Audit Readiness:
Maintain QC documentation for internal and external regulatory inspections (USFDA, EMA, CDSCO, etc.).
Cross-Functional Support:
Collaborate with QA, R&D, and manufacturing to ensure timely batch release and technical alignment.

Preferred candidate profile

Special Skills

Hands-on knowledge of
bioanalytical techniques
(e.g., SEC-UPLC, ELISA, SDS-PAGE, RP-HPLC, DLS) and protein characterization.
Familiarity with electronic documentation systems, Empower/ Chromeleon/Openlab) and MS Office.

Soft Skill

Communication: Clear and concise verbal/written communication for cross-functional interactions and report writing.

Time Management:

Collaboration & Teamwork:

More Jobs at Premas Biotech

Assistant Manager - Production/Manufacturing

Manesar

7.0 - 9.0 yrs

INR 7 - 9 Lacs

Executive/Sr Executive - Downstream Manufacturing

gurugram, manesar

2.0 - 4.0 yrs

INR 2 - 4 Lacs

Executive/ Senior Executive - Upstream Processing, Manufacturing

manesar

2.0 - 5.0 yrs

INR 4 - 5 Lacs

Executive Assistant To Managing Director

manesar

5.0 - 10.0 yrs

INR 8 - 12 Lacs

Hr Executive And Generalist

manesar

3.0 - 6.0 yrs

INR 4 - 5 Lacs

Mock Interview

Practice Video Interview with JobPe AI

Start Job-Specific Interview

Start Your Job Search Today

Browse through a variety of job opportunities tailored to your skills and preferences. Filter by location, experience, salary, and more to find your perfect fit.