Executive – Validation Services

CellTricks Biotech Pvt Ltd; Bengaluru; Vor Ort; INR 600.000 - 1.200.000; Vollzeit

Zusammenfassung

CellTricks Biotech Pvt Ltd in Bengaluru is expanding its Validation Services and seeks an Executive - Validation Services to support and execute laboratory validation activities, documentation, quality practices and compliance.

You will coordinate microbiological and physicochemical studies for filter validation, prepare SOPs and reports, maintain safety records, and assist audits.

Qualifikationen

• Master's degree in Microbiology, Biotechnology or related field.
• 1-3 years of pharma/biopharma or contract manufacturing experience.
• Knowledge of analytical testing procedures (microbiological tests, media prep).
• Awareness of GLP and GDP requirements.
• Knowledge of LIMS, ELN and MS Office tools.

Aufgaben

• Coordinate and execute microbiological and physicochemical studies for validation projects.
• Complete data forms, interpret results, and document test results per SOPs.
• Inform manager of deviations and initiate investigations for OOS or protocol issues.
• Prepare SOPs, qualification protocols/reports, and technical documentation.
• Support instrument maintenance, inventory management, and safety records.
• Assist audits and ensure compliance with QA and safety manuals.
• Coordinate storage and disposal of hazardous waste per SOPs.

Kenntnisse

Analytical testing procedures

LIMS

MS Office

Ausbildung

Master's degree in Microbiology/ Biotechnology

Tools

LIMS

ELN

Microsoft Office

Jobbeschreibung

Location: Bangalore
Experience: 1-3 Years
Qualification: Master's degree in Microbiology, Biotechnology, or a postgraduate qualification in a related field.
Job Type: Full-Time
Joining: Immediate Joiners Preferred

About the Role

CellTricks is expanding its capabilities and is coming up with Validation Services in Bangalore. We are looking
for an Executive - Validation Services to support and execute laboratory validation activities, documentation,
quality practices, and compliance in line with approved protocols and SOPs.

Key Responsibilities

• Coordinate and execute microbiological and physicochemical studies for filter validation projects in
  accordance with validation protocols and SOPs, following GLP and considering GDP principles as
  applicable.
• Complete laboratory data forms, interpret results, submit records for approval, and document test results
  in the specified format in accordance with Good Documentation Practices.
• Inform the Manager of deviations related to protocols or test execution, and initiate and complete
  investigations for protocol deviations or out-of-specification results.
• Prepare SOPs, EOPs, qualification protocols and reports, technical reports, and related documentation.
• Support routine maintenance of departmental instruments, oversee third-party maintenance and repairs,
  and assist with inventory management.
• Ensure laboratory compliance with Company Laboratory Quality Assurance and Safety Manuals; prepare
  for and participate in customer and ISO audits.
• Ensure appropriate storage and disposal of hazardous waste; maintain safety records and MSDS;
  coordinate preparation and maintenance of microbial culture strains, culture media, test solutions, and
  reagents as per SOPs or test requirements.
• Perform other laboratory-related tasks as assigned by the Manager.

Key Requirements

• Candidates with experience in bioprocess filtration validation services are highly preferred.
• Master's degree in Microbiology, Biotechnology, or a postgraduate qualification in a related field.
• 1-3 years of relevant experience in pharmaceutical, biopharma, or contract manufacturing environments.
• Knowledge of analytical testing procedures, including microbiological tests such as growth promotion
  testing and media preparation.
• Awareness of calibration and qualification activities, and knowledge of sterilizing-grade filter applications
  in pharma or biopharma.
• Good understanding of GLP and GDP requirements.
• Knowledge of or hands-on experience with LIMS, ELN, and Microsoft Office tools.