QA/QC job vacancy at Haridwar in Psychotropics India

Psychotropics India

Job Details / Candidate Eligibility Criteria

2 persons in Q.C/MICROBIOLOGIST Section and 01 for ENGINEERING SECTION.

1. Q.C/MICROBIOLOGIST:-
• EXPERIENCE- 08 to 10 Years
• QUALIFICATION- M.SC Microbiologist
• SALARY - 40k to 45k
• DESIGNATION- Sr. Executive
• REQUIREMENTS – 02 person
• RESPONSIBILITIES-
I. Preparation of standard operating procedure for Microbiology Laboratory.
II. Participate in OOS investigation related to microbiology.
III. Review all Documentation related to microbiology.
IV. Review record and reports of Raw material, Finish product, Stability sample, Process validation samples and other samples related to microbiology.
V. Distribution and management of Water Sample ,Raw material, Finish product, Stability Sample, Process validation samples and other samples.
VI. Review the Microbiology Laboratory Calibration Record of Instrument and Equipment.
VII. To ensure the operation and calibration of all instrument as per their respective procedure.
VIII. Preparation of Annual summery report of Environment monitoring trends.
IX. Co-ordinate to other department like Production, QA, Engg, Store, HR and outside parties also for smooth the process.
X. Review and update all STP, SPS, SOP & Validation protocol related to products or exiting system.
XI. Check all samples like Sterility, BET, EM,GPT, MLT tube & plates.
XII. Maintain Good Laboratory Practices and laboratory safety in the laboratory.
XIII. Any other responsibility assigned by department head.

2. ENGINEERING DEPARTMENT (QMS DOCUMENTATION):-

• EXPERIENCE- 5-6 years in Pharmaceutical Industry
• QUALIFICATION- B Tech in Mechanical/Electrical Engineering
• SALARY- Negotiable
• DESIGNATION- Executive/Sr. Executive
• REQUIREMENTS- 01 Person
• RESPONSIBILITIES-

I. Knowledge of documentation work over preventive maintenance, Breakdown and Daily log books of machines.
II. Knowledge of Validation & Qualification of machinery’s i.e. IQ,OQ,PQ, DQ and able to prepares SOPs
III. Knowledge of the operation of SAP module (PM module, Calibration, Breakdown, Incidents.
IV. Knowledge of preparation, review & execution of all QMS documents related maintenance such as Incidence, CAPA, risk assessment analysis, deviation, change control, qualification reports etc.
V. Knowledge of injectables machinery’s in Ampoule line, Vial line & Dry Powder Injection, HVAC System, water system etc
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