Senior Executive - QC analytical

Enzene Biosciences Ltd; Maharashtra; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Enzene Biosciences invites applications for Senior Executive in Quality Control at Chakan, Pune. The role focuses on analysis of in-process and finished products, calibration of QC instruments including HPLC/UHPLC, and preparation of essential QC documentation.

Candidate should have 6–8 years of hands-on QC experience with CEX/SE/RP-HPLC, ELISA, RT-PCR and Capillary Electrophoresis, and be proficient in GMP/GLP/GDP practices with strong communication and teamwork skills.

Qualifications

• Masters degree required in science/biotech or related field.
• 6–8 years of hands-on quality control experience with analytical methods.
• Experience in GMP/GLP/GDP environments preferred.

Responsibilities

• Analyze in-process, drug substances, drug products, stability and study protocol-based samples.
• Calibrate and maintain QC instruments like HPLC/UHPLC, plate readers, pH meters and related devices.
• Qualify and reconcile reference standards in QC.
• Prepare essential QC documents: specifications, SOPs, CoA, MTP, MVP, MVR, MTR.
• Oversee analyst qualification and training within routine training management.
• Initiate and close change controls and CAPA within due dates.
• Maintain proficiency in CEX-HPLC, SE-HPLC, RP-HPLC, ELISA, RT-PCR and Capillary Electrophoresis.
• Demonstrate good communication, teamwork, and shift adaptability.
• Adhere to GMP/GLP/GDP practices in QC and related procedures.
• Initiate/investigate incidents, deviations, OOS and OOT.

Skills

CEX-HPLC

SE-HPLC

RP-HPLC

ELISA

RT-PCR

Capillary Electrophoresis

Education

M.Sc./M.Pharm or Masters in Biotech

Tools

HPLC systems

UFLC systems

Maurice systems

Plate reader

pH meter

Osmometer

Job description

• Responsible for analysis of in-porcess, drug substances, drug product, stability and study protocol-based samples.
• Responsible for instrument calibration and maintenance pertaining to quality control operations like HPLC systems, UFLC systems, maurice systems, plate reader and other simple instruments like pH meter, osmometer and etc..
• Responsible for qualification activity and reconciliation of reference standard in Quality control department
• Responsible for Preparation of Documents like Specification, STPs, TDS, SOP, CoA, MTP, MVP, MVR, MTR.
• Responsible for Analyst qualification activity and effective training completion as part of routine training management.
• Responsible for initiation and closure of change control and CAPA within its due date.
• Should have technical proficiency in CEX-HPLC, SE-HPLC, RP-HPLC, ELISA, RT-PCR and Capillary Electrophoresis methods.
• Should have good comminucation skills, team work and adaptability to work in shifts.
• Should have exposure in the GMP environment to adhere the GMP, GLP and GDP practices.
• Responsible for initiation and investigation of incident, deviations, OOS and OOT.
• Responsible for to follow GMP, GLP, GDP and DI procedure in the quality control department

Company: Enzene Biosciences

Designation: Senior Executive

Office Location: Chakan, Pune

Responsibilities

• Responsible for analysis of in-porcess, drug substances, drug product, stability and study protocol-based samples.
• Responsible for instrument calibration and maintenance pertaining to quality control operations like HPLC systems, UFLC systems, maurice systems, plate reader and other simple instruments like pH meter, osmometer and etc..
• Responsible for qualification activity and reconciliation of reference standard in Quality control department
• Responsible for Preparation of Documents like Specification, STPs, TDS, SOP, CoA, MTP, MVP, MVR, MTR.
• Responsible for Analyst qualification activity and effective training completion as part of routine training management.
• Responsible for initiation and closure of change control and CAPA within its due date.
• Should have technical proficiency in CEX-HPLC, SE-HPLC, RP-HPLC, ELISA, RT-PCR and Capillary Electrophoresis methods.
• Should have good comminucation skills, team work and adaptability to work in shifts.
• Should have exposure in the GMP environment to adhere the GMP, GLP and GDP practices.
• Responsible for initiation and investigation of incident, deviations, OOS and OOT.
• Responsible for to follow GMP, GLP, GDP and DI procedure in the quality control department

Educational Qualifications Preferred

• M.SC., M. Pharm or Master degree in Biotech or relevant subjects

Required Work Experience

• 6-8 years of relevant hands on experience in the tasks such CEX-HPLC, SE-HPLC, RP-HPLC, ELISA, RT-PCR and Capillary Electrophoresis analysis (Maurice system), chromatographic and plate based data review and IRS maintenance.