Biosimilars Manufacturing QMS | Biocon

Biosimilars Manufacturing QMS opportunity

Experience: 7-12 years

Qualification: B Tech/ M Tech

Overall QMS responsibility of manufacturing operations and facility management.
Ensure compliance (GMP, GXP) with appropriate SOP’s as per regulated market requirements
Ensure compliance with appropriate SOP’s, policies and guidelines for operations in manufacturing plant
Monitor performance metrics, draw conclusions, and make recommendations in the manufacturing review meeting (MRM) forum
Identifying compliance issues and product quality issues and championing solutions
To Identify risks and escalate them to the department head and relevant functional heads.
Identifying needs for performance improvement and interacting with users and training departments
Responsible for identification of repeat and overdue QMS events and ensure proper CAPA is in place to stop such events
To review all , Protocols and other closure reports and ensure they comply to regulatory audits.

Interested and relevant candidates can share their resume at sushmitha.101@biocon.com

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Biocon Biologics is hiring for below requirements | Injectable Production | Insulin/Biologics Production | SCM | Automation | Packing Visual Inspection | Bangalore | B.Sc | M.Sc | B.E | B.Tech

Looking for QC Head- Analytical for Biocon, Malaysia.

Candidates with relevant experience in heading QC in Sterile API, Drug Products can share their profiles to prasad.n101@biocon.com

Biocon Walk-In Interview, Bangalore - 23/9/18 , We are hiring! Don't miss the opportunity to work with Asia's leading Biopharmaceutical organisation.

We are hiring! Don't miss the opportunity to work with Asia's leading Biopharmaceutical organisation.

Get ready for the walk-in interview at #Bangalore on 23rd September. For more details visit:

Position: Jr. Executive / Executive
Department: Generic Formulation Production & Packing Operator
Job Description: Candidate should be Diploma / B.Sc / B.Pharm with 1-4 years of relevant experience in OSD Formulation manufacturing & packing. Should have exposure in handling operation of granulation equipment’s, compression machine (both high containment and standard), coating, bottle & blister packing machine, secondary packing and CPIR system. Sound knowledge in cGMP. Pharmaceutical industry experience mandatory.

Biocon Limited Walk In Interview For Multiple Positions B.Sc, M.Sc, M.Pharm, B.Pharm at 23 Sep

Walk-In Interview, Bangalore - 23/9/18
1. Position: Jr. Executive / ExecutiveDepartment: Generic Formulation Production & Packing Operator

Job Description: Candidate should be Diploma / B.Sc / B.Pharm with 1-4 years of relevant experience in OSD Formulation manufacturing & packing. Should have exposure in handling operation of granulation equipment’s, compression machine (both high containment and standard), coating, bottle & blister packing machine, secondary packing and CPIR system. Sound knowledge in cGMP. Pharmaceutical industry experience mandatory.


2. Position: Sr. ExecutiveDepartment: Generic Formulation Production & Packing Line Supervisor

Job Description: Candidate should be B.Sc / B.Pharm/ M.Sc / M.Pharm with 5-7 years of relevant experience in OSD Formulation Facility. Should be able to handle process challenges and have experience in supervising the OSD manufacturing and packing line independently for regulated market. Well versed with cGMP. Pharmaceutical industry experience mandatory.


3. Position: Asst. ManagerDepartment: Generic Formulation Production & Packing Shift Supervisor

Job Description: Candidate should be B.Sc / B.Pharm/ M.Sc / M.Pharm with 8-10 years of relevant experience in OSD Formulation facility. Should be capable of managing the entire shift operations independently. Well versed with cGMP. Previous experience working with regulated OSD facility would be preferred.

Note: All positions are for Bangalore location only. All positions would require working in shifts.
Candidates should bring one passport size photograph, two copies of CV, last 3 months payslips, copies of educational certificates, previous work experience certificates & salary annexure. For any queries please reach at pranjali.waghaye@biocon.com


Venue:Biocon Limited,
20th KM, Hosur Road,
Electronic City,
Bangalore- 560100 (Gate 2).
Time: 9:00 AM to 12:00 PM

Recruitment Drive for Downstream Biologics on 25th Nov @ Biocon Park

Time and Venue

Walkin Interview on 25th November from 9 AM onwards

Syngene International Ltd Biocon Park, Plot No.2&3, Bommasandra Jigani Link Road Bommasandra Phase-IV Bangalore

1.  Expertise in purification of recombinant proteins and monoclonal antibodies in mammalian cell culture facility.
2. Exposure to purification of wide variety of proteins (novel and biosimilars)
3. Experience on Scale up, technology transfer, and purification operation at large scale
4. Experience in handling downstream process equipments such as continuous centrifuge, depth filtration ,chromatography system, column chromatography, column packing and filtration skids
5. Experience in the Process equipments Commissioning and Qualification and change management.
6. Experience in the Process equipment Commissioning and Qualification

Packaging Engineer - Formulations

Company Name: Biocon

Experience : 6-10 years

Qualification:  M. Pharm Pharmaceutics

Job Description :

• Developing multifunctional, cost effective, eco-friendly packaging solutions to meet specific needs and requirements.. 
• Working on devices i.e. auto-injector, Pens for Cartridges for US, EU & other major markets.
• Development of change part for solid oral dosage form (blisters and strips) as primary & secondary packs for injectable products like Vial, Ampoule and PFS.

Apply 

• Send Resumes to:  ruchi.panjwani@biocon.com

Technology Transfer - Formulations

Company Name: Biocon

Experience : 7-10 years

Qualification:  M. Pharm Pharmaceutics

Job Description :

• Preparation on technology transfer strategy with timelines, gap analysis, technology dossier and execution plan for both Potent & Non-potent compounds.
• QbD based optimization of process by following DOE designs to ensure robust manufacturing process before transfer to site.
• Monitoring execution of the TT demo batches, optimization batches & registration batches for USA & EU markets.
• Experience of handling both Solid oral as well parenteral products would be an added advantage.

Apply 

• Send Resumes to:  ruchi.panjwani@biocon.com

Regulatory Affairs Formulations

Company Name: Biocon

Experience : 3-6 years

Qualification:  M.Sc. / M.Pharm /

Job Description

• Compilation of eCTD format & review of dossier (ANDA, MAA, ANDS) including technical data package.
• Review of Batch records, specification, art work and packaging material, analytical method validation documents, development documents, PDR & labeling.
• Coordination with R&D in evaluating and finalizing QbD elements at different stages of product development. Write high quality deficiency response to regulatory authorities.

Apply 

• Send Resumes to:  ruchi.panjwani@biocon.com

Regulatory Affairs Biologics

Company Name: Biocon

Experience : 4-8 years

Qualification:  M.Sc. / M.tech Biotechnology / Ph.D. Life Science / Biotechnology

Job Description

• Write & review regulatory submissions like IND, IMPD, MAA, NDA, DMF and documents for regulatory advices.
• Guidance to cross functional teams on regulatory expectations for US, EU, Japan and major markets.
• Ensuring regulatory compliance in cross functional teams and managing cross functional team deliverables.
• Review of CMC, clinical, bioanalytical development related documents & ensure compliance to CTD requirements.

Apply 

• Send Resumes to:  ruchi.panjwani@biocon.com