Freshers Microbiology QC Executive Job at Zentiva – Apply Online Now

Freshers Microbiology QC Executive Job at Zentiva – Apply Online Now

Executive I – QC, Pharma (Micro)

Locations: India / Ankleshwar

Time type: Full time

Posted on: Posted Yesterday

Job requisition ID: R2466811

KEY ACCOUNTABILITIES

Microbial Analysis and Quality management for Stability study:

• Carry out microbial sampling & analysis for Raw Materials, Intermediates, Finished Products and other samples of Pharmaceuticals, Chemistry and Pilot plant samples.
• Perform Bacterial Endotoxin [LAL] Tests.
• Sampling/Analysis for Process Validation, Cleaning Validation, method validation, hold time study samples and Stability Samples.
• Microbial Monitoring of Controlled Area Environment for Pharmaceuticals, Chemistry, Pilot plant and QC Microbiology.
• Microbial Analysis and sampling of Potable water, Process water and Purified Water System of Energies, Pharmaceuticals, Chemistry and Pilot plant.
• Trending and review of microbial results for MLT of starting materials, intermediates, Finished Products, Water and Controlled area for Pharmaceuticals, Chemistry and Pilot plant.
• Handling of microbial Pure cultures, microbiological media and all instruments of microbiology department.
• Notify the system user / system owner / manufacturing, as the case may be, any OOS / OOT results.
• Assist, Manager Quality Control in Laboratory Investigation of OOS/ OOT results.
• Maintaining & reviewing laboratory raw data related to testing activity.
• Preparation of Stability study protocols and related documents.
• Preparation of stability analysis report and stability study report.
• Review guidelines, related to stability study.
• Maintaining and monitoring stability chambers, stability samples loading & withdrawal and related activities.
• Planning for sample collection.
• Labeling and storage of stability samples.
• Co-ordinate with Production / packing, warehouse, QA/QC related to stability study.

Calibration & Performance Verification

• Coordinate qualification and validation activities of instruments and equipment.
• Perform Calibration of the equipment’s as per schedule.
• Participate actively in area, system, equipment qualification and process / cleaning validation activities for microbiological aspects.
• Perform the Method validation of the products.

Documentation

• Maintenance and review of raw data related to microbiology laboratory operations including media preparation, sterilization, growth promotion tests, culture traceability / maintenance and microbial test conducted in the department.
• Preparation of SOPs, Formats, specification and related documents for QC Microbiology.
• Carry out training program on revised new SOPs and other activities in the department.
• Support to preparation of validation & qualification protocols & reports for Pharmaceuticals, Chemistry and Pilot plant.

Management of laboratory Consumables

• Identifying and planning requirement for laboratory consumables and monitoring the stock of chemical, Media, glassware, log books and printed material.

Co ordination

• Coordinating with production, and warehouse for analytical activities.
• Coordinating with Pharmaceuticals, Chemistry and Pilot plant for analytical activities.

Other

• Compliance to HSE Requirements for QC Microbiology.
• Identifying and correcting unsafe conditions or behaviors and promptly reporting other potentially hazardous situations.
• Carrying out any other assignments or projects as per the instruction of the Department Head to meet with the organizational objectives and priorities.

Education / Experience

• Post Graduate in Microbiology.
• 0 to 5 years in a Pharmaceutical Company.