Telephonic Interview for QC / QA / Production / Microbiology Departments @ SAFE Parenterals Ltd

 

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