SOVEREIGN Pharma was established in 2003 as a Contract Manufacturing Organization (CMO) with a strong focus on manufacturing high quality injectables for pharmaceutical companies worldwide.We are a quality focused and WHO-GMP certified manufacturing facility for terminally sterilized as well as aseptically filled injectables in Ampoules, Vials (Liquid and Lyophilized), Pre-fill Syringes and Sterile Pre-crimped Cartridges.
Job Description
1) QA Documentation : Technology transfer ; SOP preparation and management ; Documentation management ; Training management ; Batch records review management & Artworks management
2) QA Validation :
- – Preparation, review & execution of the equipment qualification i.e. Autoclave validation, Tunnel –validation, Vial / Ampoule washing machine validation, Lyophilizer validation.
- – Preparation, review & execution of the utilities qualification i.e. HVAC & LAF validation, Compressed air validation, Nitrogen gas validation, Water system validation.
- – Preparation, review & execution of the initial qualification of the equipment / utilities i.e. DQ, IQ,
OQ & PQ of the equipment / utilities - – Handling of the Process validation.
- – Handling of the Cleaning Validation
- – Handling of the Media fill activity.
- – Handling of the QMS activities i.e. Change control, Deviation, CAPA
- – Handling of the Risk Assessment.
3) IPQA :
- Responsible for line clearance and in process checks for all areas of Small Volume Parenteral
- Responsible to maintain the document as per cGMP.
- Ensuring manufacturing practices asper cGMP
- Conducting shop floor inspection & reporting of the same to the department head
- Conducting shop floor training of the staff
- Responsible for initiating Change Control/Deviation/Non-Conformance /Incident / CAPA
- To assist the Head of Department for preparation of regulatory inspection.
- Recording and verification of BMR/ BPR and related activities
- xecuting the validation/revalidation activity of Autoclave / DHS / AHU / Ampoule & Vial Washing Machine
- Any other responsibilities assigned by the Head of Department
QC Vacancies – QC Executive
No – 1
Experience – 4- 7 years
Job Responsibilities :
- Hands on experience on HPLC /GC
- Handling of instruments like Auto titrator, Uv and IR
- Wet and Dry analysis.
- Analysis of Raw materials, Finished Good and other analytical samples
- Review of RM, FP, Stability, calibration reports.
- Planning and execution of analytical samples.
- Investigation of deviation PCC, OOS, Job incident etc.
- revision of reports received from CTL, Regulatory compliance
Date: 3rd December, 2022
Time: 9.30 AM – 5.30 PM
Venue: Sovereign Pharma Pvt. Ltd. | Survey No. 46/1-4, Kadaiya Village | Nani Daman – 396210
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