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Post : OFFICER - Q.C
Job Description
- Perform data review in accordance with the cGMP/Data Integrity requirements. Analyzing the data with respect to ALCOA principles
- Thorough knowledge in the area of stability testing and all the applicable regulations
- Ensure proper planning for execution of review within window.
- To ensure immediate escalation of issues not in conformity with applicable procedures /policies etc.
- Results reviewing into the applicable LIMS system as per established procedures.
- Knowledge of maintenance and qualification/calibration (execute) of lab equipments. Knowledge of FMEA analysis, risk analysis for instrument qualification
- Up to date knowledge of current regulatory requirements and pharmacopoeil updates
- Technical/scientific support to other labs within the premise.
- Participate in project teams as analytical technical team member.
- Attend (in-house) seminars, scientific meetings in own field.
- Comply with the applicable responsibilities according to various procedures.
- Training of colleagues (if applicable).
- Initiate and document deviations in applicable Event Tracking System in timely manner.
- Initiate (if applicable) and implement CAPA’s in timely manner.
- Compilation of work instructions and standard operating procedures.
- Initiate applicable change requests according to the procedures.
- Execute the tasks according to the cGMP guidelines.
- Following Procedures & self-upgrade knowledge of key areas.
Employee safety and health
Ensure that respective guidelines and SOPs are followed
Environmental Care
Ensure that respective guidelines and SOPs are followed
Quality
Ensure that respective guidelines and SOPs are followed
Financial management
Ensure that respective guidelines / practices are followed
Identify cost saving opportunities
Business Policy
Follow all applicable company business policies.
MIS Policy
Follow all applicable company business policies.
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Credo and Leadership Imperatives
o Respect and make the credo values respected.
o Stimulate and encourage new ideas and improvement processes.
o Practice and implement Leadership imperatives (connect, deliver, lead, and shape) for customer satisfaction, innovation, mastering complexity, collaboration.
o Cooperate efficiently with the different partners.
Candidate Profile
Minimum Qualification for the position
Science/Pharmacy Graduate.
Deputy Arrangement (active/Passive):
Active representation: the employee represents the following persons in case of absence
Passive representation: in absence, the employee is represented by
Additional Information:
Qualification: B.Pharm, B.Sc
Location: Maharashtra-Greater Mumbai
Functional Area: QC
Industry Type: Pharma/Biotech/Clinical Research
End Date: 30th August, 2017
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