Hetero Biopharma Limited – Hiring for IPQA / Production – USP / DSP

Hetero Biopharma Limited, The leading edge of Hetero Group, Hetero Biopharma, is steadily establishing itself as a path breaking Biosimilar developer. As a strong R&D driven company offering some of the blockbuster Biosimilar Drugs, we at Hetero Biopharma are bringing about a paradigm shift in the way patients suffering from various chronic conditions are treated.

 

HETERO BIOPHARMA HIRING FOR IPQA

• Experience 1-5 Years,
• Qualification: M. Pharm / B. Pharm / M.Sc. Biotechnology / Biochemistry
• Job location : Hetero biopharma, Jadcherla, Hyderabad, Telangana state
• Preferable Biologics / Injectable

Job Description:

• Performed Activities in In Process Quality Assurance (IPQA).
• To perform ipqa activities on the shop floor and responsible for giving the line clearance in each stage ofdispensing of approved raw materials, Manufacturing (compounding activity) and Filtration, Filling, Stoppering and Sealing activity.
  And giving line clearance for Autoclave sterilization loads, CIP, SIP
• activities and vial washing activities.
• Have involved and had knowledge on various types of sterile injectable presentations like vials, Cartridges, Prefilled syringes and Ampoules.
• Had involved and worked with verification and monitoring of raw material Dispensing, Compounding and filtration, filling, stoppering and sealing activities at each and every stage.
• Responsible for cleanness of change rooms and respective areas, equipment’s, vessels. And review of Autoclave charge reports, CIP and SIP reports, NVPC data, Tunnel and washing printout reports etc.
• Responsible for Sampling and to send water for injection collection samples, bulk solution(Inprocess) samples and bioburden samples, Nitrogen gas sampling, Finished product sampling for quality control and microbial tests. And review that WFI, Bulk and Bacterial endotoxins test (BET) reports.
• Review of Batch production and control records (BPCR).
• Responsible for verification of equipment log books and area log books for accurate and completeness. And to follow Good documentation practices (GDP) and current Good manufacturing practices (CGMP) requirements.
• Responsible to follow, monitor and execution of special precautions, critical parameters and storage conditions.
• To monitor and ensure environmental conditions like temperature, relative humidity, differential pressures, EMS reports during activity in Dispensing booths, Batch preparation Areas, Vial and cartridges washing areas and Filling areas. And responsible for giving line clearance and monitoring of visual Inspection activities. And to perform Acceptable Quality Limits (AQL) checks and to verify the Batch Reconciliation.
• Responsible for execution and to involve in Process validation Batches, Aseptic Media simulation (Media fill) Batches, Cleaning validation batches, Stability and Hold time Studies batches. And execution and monitoring of Interventions.

Apply Now:

• Interested candidates are requested to send your updated resume to bhagyalakshmi.bu@hetero.com & praveen.ko@hetero.com
• Note: Please mention your Resume title and mail subject as “IPQA”

 

HETERO BIOPHARMA HIRING FOR PRODUCTION UPSTREAM

• Department: Production-Upstream process
• Position: Executive/Sr. Executive
• Job location: Jadcherla, Hyderabad
• Required Experience and Qualification: M.Sc/M.Tech/B.Tech in Biochemistry, Biotechnology, Microbiology with 4 to 7 years of relevant work experience in Upstream manufacturing

Functional or Technical skills:
1. Execute all Upstream manufacturing activities in production area.
2. Hands on experience of handling single use bioreactors (200 L, 1000L & 2000L) filtration system, mixing station.
3. Hands on experience of handling single use wave bioreactors( 20/50) .
4. Monitor Batch process operation & monitoring of batch performance and data.
5. Follow and practice on-line documentation all the time.
6. Follow cGMP practices during the manufacturing activity and operations associated activities with QA, QC.
7. Ensure process equipment’s/instruments are in Qualified in state.
8. Active coordination with inter-depts. for sample submission, closure of documentation and timely execution and contribution for the assigned tasks
9. Ensure the Quality system is followed in day to day upstream operations. Identify the gaps in the system to improve.
10. Target error free operation by eliminating operational gaps in advance.
11.Active trouble shooting to minimize the various risks prior to execution and during execution.

Technical Skills:
1.Strong Hands on experience with single use bioreactors (200 L,1000L & 2000L) & single use wave bioreactors( 20/50).
2.Exposure to handle of Bio-similar proteins and Mabs projects in cGMP area.
3.Sound knowledge and awareness of GMP controls, Quality systems and regulatory aspects.
4.Experience on risk assessment tools and change management.
5.Experience on the Equipment Qualification aspects

Apply Now:

• Interested candidates are share your updated resume to bhagyalakshmi.bu@hetero.com & praveen.ko@hetero.com
• Note: Please mention your resume title and Mail subject as “Production upstream”

 

HETERO BIOPHARMA HIRING FOR PRODUCTION DOWNSTREAM

• Department: Production-Downstream
• Position: Executive/Sr. Executive
• Job location: Jadcherla, Hyderabad
• Required Experience and Qualification: M.Sc / M.Tech / B.Tech in Biochemistry, Biotechnology, Microbiology with 3 to 6 years of relevant work experience in downstream manufacturing

Functional or Technical skills:
Execute all Downstream manufacturing activities in production area.
1.Hands on experience of operate AKTA Chromatography system, filtration system, mixing station.
2.Hands on experience of packing Quikscale and BPG columns.
3.Monitor Batch process operation (including CIP and preparation downstream accessories), close monitoring of batch performance and data.
4.Follow and practice on-line documentation all the time.
5.Follow cGMP practices during the manufacturing activity and operations associated activities with QA, QC.
6.Ensure process equipment’s/instruments are in Qualified in state.
7.Active coordination with inter-depts. for sample submission, closure of documentation and timely execution and contribution for the assigned tasks
8. Ensure the Quality system is followed in day today downstream operations. Identify the gaps in the system to improve.
9. Target error free operation by eliminating operational gaps in advance.
10. Active trouble shooting to minimize the various risks prior to execution and during execution.

Technical Skills:

• Strong Hands on experience with AKTA Chromatography system & column packing, filtration unit and supporting equipments.
  Exposure to handle of Bio-similar proteins and Mabs projects in cGMP area.
• Sound knowledge and awareness of GMP controls, Quality systems and regulatory aspects.
• Experience on risk assessment tools and change management.
• Experience on the Equipment Qualification aspects

Apply Now:

• Interested Candidates share your resume to bhagyalakshmi.bu@hetero.com & Praveen.ko@hetero.com
• Note : Please mention your Resume title and Mail subject as “Production downstream”

 

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