Job Description
Roles and Responsibilities
Job Title: Quality Control (Assistant Manager /Deputy Manager)
Company: Leading Pharma API Bulk Drugs Company in Vizag Location
Designation: Assistant Manager/Deputy Manager
Reporting to: Senior Manager
No. of Positions: 2
Division: API Bulk Drugs
Department: Quality Control
Job Location:Vizag Location
Qualification: MSc (Full Time)
Years of Experience:10 to 12 Years
Salary Range: 10 LPA
Contact person: Mr.Zabi Moghal
Mobile: 8105301***
Email: za*i@bv**c.com
Roles:
- Initiation of change controls, deviations, OOS, Incidents and Invalidations and other related documents like Job/Work orders etc.,
- Departmental investigations and preparation of investigation reports.
- Preparing and review of Raw materials, intermediates, Recovery, API and packing materials Spec s, STP s along with raw data, ATR, and certificate of analysis.
- Internal audits/external audit preparation for QC.
- Maintaining data integrity in QC.
- Preparation and review of all departmental procedures like SOPs', Calibration procedures, analytical documents, Preventive maintenance procedures, Protocols, Reports, stability summary sheets and trend data sheets.
- Preparing and Review of Cleaning validation protocols, stability and hold time study protocols and its reports.
- Working standard Management.
- Procuring of Reference standards and Qualification of In-house standards.
- Maintenance of laboratory equipment and laboratory cleaning.
- Maintenance of chemicals in Quality Control.
- Handling and maintenance of stability chambers.
- Chemical and glassware indent.
- Samples sending to ETP for destruction.
- Daily monitoring and recording of Temperature and Humidity records, lab cleaning records.
- Control samples / retain samples management.
- Stability samples packing, inception, withdrawal and stability sample management.
- Review of Instrumental and Wet analysis data (HPLC, GC, UV, IR, and Potentiometer) of Raw materials, Intermediates, In-process, packing materials, Residual solvents, Finished product and Stability samples.
- To perform and review of calibrations of Instruments located in Quality control department.
- CAPA implementation.
- Coordinating with all departments for smooth operations of department.
- Good Laboratory practices and Compliance.
- To attend the cGMP and GLP trainings as per schedule and training of analysts.
- To perform the activities by following the safety norms, SOP s and adhering with company policy.
Industry: Pharmaceutical & Life Sciences
Functional Area: Production , Manufacturing , Maintenance
Role Category: Production/Manufacturing/Maintenance
Role: Quality Assurance/Quality Control Manager
Employment Type: Full Time, Permanent
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Employement Category:
Employement Type: Full time
Industry: Pharma / Biotech
Role Category: General / Other Software
Functional Area: Not Applicable
Role/Responsibilies: Quality Control (Assistant Manager)for Pharma
Contact Details:
Company: BVR People Consulting
Location(s): Visakhapatnam