1.Preparation of General testing procedure & operating procedures related to microbiology.
2.Preparation of equipments validation & qualification, method validation protocols with respect to microbiology.
3.Shall responsible for Sampling, analysis and reporting for Water for injection (WFI) Purified water, source water, potable water, processing water and Pure steam condensate LAL , Bioburden and their pathogen absence test
4.Microbiological testing support with respect to facility/ equipment/process validation / qualification in coordination with QA/ validation team.
5.Shall responsible for Testing of Microbial limit test for API, Excipients, Bulk samples, PV/CV samples and the respective method validation.
6.Shall responsible for Testing, of miscellaneous studies.
7.Shall responsible for the Microbiological assay of antibiotics and vitamin and their test method validation.
8.Shall responsible for the drain point swab sample and analysis and documentation.
9.Shall responsible for Testing of BET test for water, Raw materials, finished product and the relevant method validation.
10.Shall responsible for the Stock maintenance and initial quality control test for LAL reagents & Biological indicators and documentation
11.Shall responsible for all incubators, cooling cabinet, deep freezer temperature record maintenance and review.
12.Shall responsible for Environmental monitoring, personal monitoring, surface contact and swab tests at production facility and microbiology lab.
13.Shall responsible for the initiation, investigation coordination and suitable CAPA in case of Excursion
14.Shall responsible for all calibration, review of logbooks of the Microbiology lab equipments.
15.Shall responsible for all relevant log books, reports, Trends and file Maintenance.
16.Participate in the regulatory / customer audits.
17.Shall responsible for testing, Sterility testing of finished products; in process samples, packing materials & media fill samples, Method validation.
18.Shall responsible for coordination in the Media fill activities and the relevant support to QA.
19.Shall responsible for incident initiation, investigation coordination related to quality management system.
20.Shall maintain the Good Microbiological laboratory practice.
21.Perform the assignments (other than the above mentioned) allotted by department head from time to time.
22.Shall responsible for preparation of all types of media in the microbiology laboratory and performance of GPT for those media, distribution of the media for testing, maintenance of media & consumables stock and maintenance of related documents.
23.Shall responsible for sterilization autoclave , destruction autoclave , destruction of used and incubation completed media plates, tubes ,canisters and etc.
24.Shall be responsible for the maintenance of culture and preparation of suspension and shall maintain related documents and review of related documents.
25.Shall be responsible for the identification the cultures to be identified and qualification of Vitek-2 instrument and maintenance and review of its related documents.
26.Shall be responsible for supervision, coordination & monitoring of compliance for Microbiological testings and method validation.
27.Shall monitor the cleanliness of the Microbiology department
Generic QM experience and successful track record in injectable/formulationare highly preferred. Good documentation and writing skills and Candidates must be self motivated with excellent written and verbal communication skills. Good interpersonal and project management skills are critical for this position.