SAFE Parenterals Ltd – Telephonic Interview for QC / QA / Production / Microbiology Departments – Apply Now
Greetings from Pranaya Group
We have an Urgent requirement in SAFE PARENTAL at Narasaraopet, Guntur Dist. for the following departments
- Preference will be given to those who can Join immediately and are nearby of Narasaraopet or willing to really relocate to Narasaraopet
Department: Quality Control (QC) (Injectable Experience)
- Position: Manager
- Experience: 12-15 Years
- Openings: 01
- Location: Safe Parental, Narasaraopet, Guntur Dist.
- Qualification: B.Pharm and M.Pharm-Pharmacy
Job Description: NOTE: Please Mention in Subject as “QC Manager”
- Implementation of the GLP
- Regulatory knowledge & guidelines – GLP, Schedule M, ICH, WHO TRS etc
- Ability to maintain coordination with their internal and external stakeholder for their smooth and timely functioning & timely release of RM, PM, in-process, FG, & Stability samples.
- Ensure compliance to perform the Preventive Maintenance/AMC of laboratory associated instruments /equipment.
- Ensure scheduled preparation, review & approval of the SOPs, STPs, GTPs and analytical data sheets with respect to Quality control Lab.
- To carry out the review and approval of qualification validation/Calibration data of the Quality control Instruments/equipment’s
- To carry out the activities related to Quality Management System for new installation of the new instruments/equipment (i.e. Change Control Requests / protocols etc.)
- To ensure cGMP & hygiene in laboratory. Reference Standard/ Working Standard management.
- Ensure the continuous supply management of, Reagents/chemicals/Columns/solvents and glassware in the Lab.
- Approval of analytical Data of Finished Goods, Stability, Raw materials, Packaging materials, Primary Standard and working standard.
- Management and handling of stability studies.
- Responsible for coordination with PPC for mfg plan & timely release/rejection.
- Responsible for procurement of Lab equipment/instrument and it’s timely.
- Qualification with complete documentation (i.e. URS, FRS, DQ, IQ, OQ, PQ)
- Responsible for coordination with IT department to ensure timely execution of CSV.
- Responsible for SAP, QM module application in QC.
- Responsible to maintain safety in lab.
Desired Candidate Profile
Candidates from Liquids /Dry Powder injection /Liquid injections (Ampoules/Vials)/ and LVP/SVP etc will be preferred.
Department: Quality Assurance (QA) (Injectable Experience)
- Position: Executive
- Experience: 02-05 years
- Openings: 04
- Location: Safe Parental, Narasaraopet, Guntur Dist.
- Qualification: B.Pharm and M.Pharm-Pharmacy
Job Description: NOTE: Please Mention in Subject as “QA Executive”
- Complete Experience in Quality Assurance of Pharma Manufacturing Injectable setup.
- Responsible for Handling of Change control, Deviation, OOS, Market Complaint, Document Control, Equipment Qualification, process Validation, Cleaning Validation, Stability Study, Calibration of instrument, IPQA activity
- Good knowledge of Various International Audit at Plant level.
- Start to end process knowledge and understanding of QA profile.
- Good in Team Handling and training.
- Good communication skills
- Flexible and capable of managing team
- Should have good problem-solving skills and presence of mind.
- Must be able to keep calm and make quick, clear decisions while coping with pressure
- Understand the techniques and processes.
- Regulatory knowledge & guidelines – GLP ,Schedule M, ICH, WHO TRS etc
Department: Production
- Position: Production Head (Asst/Deputy Manager)
- Openings: 02
- Location: Safe Parental, Narasaraopet, Guntur Dist.
- Qualification: Any Degree
- Experience: 10 to 15 years
Job Description:
- For Experience of running and managing plant for producing LVP/SVP filling & another machine.
- Managing stock control and inventory checks.
- Having a keen eye on budgets and budgetary changes.
- Communicating changes in an order process to relevant parties.
- Good knowledge of regulated environment and CGMP & to motivate a team of professionals and train the juniors.
- Set daily/weekly/monthly objectives and communicate them to employees
- Organize workflow by assigning responsibilities and preparing schedules
- Oversee and coach employees
- Ensure the safe use of equipment and schedule regular maintenance
- Check production output according to specifications
- Submit reports on performance and progress
- Identify issues in efficiency and suggest improvements
- Train new employees on how to safely use machinery and follow procedures
- Enforce strict safety guidelines and company standards
- Supporting the MD or executive team’s vision and process ideals.
Requirements
- Preference will be given to those who are nearby of Narasaraopet or willing to really relocate to Narasaraopet
- Proven experience as Production Supervisor or similar role
- Experience in using various types of manufacturing machinery and tools
- Advanced skills in MS Office
- Organizational and leadership abilities
- Communication and interpersonal skills
- Self-motivated with a results-driven approach
- Problem-solving skills
Department: Microbiology (Injectable Experience)
- Position: Executive
- Experience: 02-05 years
- Openings: 04
- Location: Safe Parental, Narasaraopet, Guntur Dist.
- Qualification: B.Pharm and M.Pharm-Pharmacy
Job Description: NOTE: Please Mention in Subject as “Micro Analyst”
- Environment Monitoring (Production-Block-A, B, C)
- Following activity shall be Performed Settle plate monitoring, Active Air sampling and Surface monitoring, Personnel monitoring.
- Plate enumeration and plate observation
- Gowning qualification
- Media reconciliation
- Plates incubation
- Plates observation and report
- Sterility analysis of Raw material, finished, Packing material and in- Process material
- Media preparation for Water analysis, Sterility analysis, MLT Analysis and PET Analysis.
- Autoclave loads 4 cycles for Media, Miscellaneous load, Bowie-dick test and vacuum leak test
- Destruction Autoclave 2 cycles
- BET analysis of Raw material, finished, Packing material and in- Process material and Water
- Endotoxin recovery study,
- Hot air oven loads
- MLT analysis of Raw material, finished, Packing material and in- Process material
- TAMC, TYMC and Pathogen
- Daily analysis report of Environment Monitoring, Sterility, Media Preparation, Culture Maintenance, BET, MLT, WATER
- Miscellaneous Protocol preparation and Report Preparation
Shortlisted candidates will have initial Telephonic interview. Interested Candidates, please share us your updated resume/profile (with Photo) along with CTC Letter to hr.corporate@pranayagroup.com
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