Deputy Manager-QC (Vaccine-Product Testing)

Zydus Group; Ahmedabad District; On-site; INR 600,000 - 900,000; Full time

Job summary

Zydus Group seeks a skilled analytical sciences professional to lead method validation, stability studies, and instrument calibration in a GMP/GLP environment. The role requires hands-on work with pH meters, HPLC, ELISA, RT-PCR, and other analytical techniques while coordinating with maintenance and external labs.

You will develop SOPs, protocols, and study plans, maintain good documentation, and ensure compliant operations under QMS guidelines such as OOS/OOT changes.

Qualifications

• Shall be well versed with cell based assays, Virus titration, RTPCR and immuno-chemical assays.
• Experience in handling QMS elements like OOS, OOT, change control and deviation are added advantage.
• To perform/Monitor activities in compliance with GMP/GLP.
• Experience in preparing SOPs, specification and study protocols
• To prepare protocol and execute method validation
• Experience in handling stability studies and maintaining Good documentation practice.
• Should possess basic skills in MS-Office, LIMS & SAP

Responsibilities

• Coordinate with maintenance department or third party labs as and when required.
• Handle GMP/GLP/GDP record keeping and documentation.

Skills

Cell-based assays

Virus titration

RTPCR

Immuno-chemical assays

Team leadership

MS-Office

LIMS

SAP

Biochemical assays

Electrophoresis

Tools

pH meter

Analytical balance

Karl Fischer

Real time PCR

ELISA

HPLC

Dionex

UV-Spectrophotometer

Multimode plate reader

Job description

• Shall be well versed with cell based assays, Virus titration, RTPCR and immuno-chemical assays.
• Ability to Lead Team/
• Instrument knowledge on pH meter, Analytical balance, Karl Fischer, Real time PCR and ELISA
• Knowledge in calibration and qualification of equipment and instruments.
• Experience in handling QMS elements like OOS, OOT, change control and deviation are added advantage.
• To perform/Monitor activities in compliance with GMP/GLP.
• Experience in preparing SOPs, specification and study protocols
• To prepare protocol and execute method validation
• Experience in handling stability studies and maintaining Good documentation practice.
• Role shall require to coordinate with maintenance department or third party lab as and when required.
• Experience in handling HPLC, Dionex, UV-Spectrophotometer, Multimode plate reader and ELISA
• Shall be well versed with Biochemical assays (Protein, O-acetyl) immuno-chemical assays and electrophoresis,
• Knowledge in calibration and qualification of equipment and instruments.
• To perform/ monitor activities in compliance with GMP/GLP/GDP and record keeping.
• Experience in preparing SOPs, Specification, STPs and Study protocols
• To prepare method validation protocol and execute method validation.
• Experience in handling stability studies and maintaining records.
• Role shall require to coordinate with engineering/ maintenance department or third party labs as and when required.
• Should possess basic skills in MS-Office, LIMS & SAP