Jr. Executive @ Syngene International Ltd Master’s degree/ bachelor’s degree in pharmacy, Master’s degree in Pharmaceutical Sciences
Syngene International
Ltd. (BSE: 539268, NSE: SYNGENE, ISIN: INE398R01022), is an integrated
research, development, and manufacturing solutions company serving the global
pharmaceutical, biotechnology, nutrition, animal health, consumer goods, and
specialty chemical sectors. Syngene’s 4500+ scientists offer both the skills
and capacity to deliver great science, robust data management and IP security,
and quality manufacturing at speed, to improve time-to-market and lower the
cost of innovation. With a combination of 1.9 Mn sq ft of specialist discovery,
development and manufacturing facilities, as well as dedicated research
facilities for Amgen, Baxter, Bristol-Myers Squibb and Herbalife, Syngene works
with biotech companies pursuing leading edge science as well as multinationals
including GSK and Merck KGaA.
Key Result Areas
Role-specific:
- Maintain good aseptic behaviour inside Biologics
operations facility.
- Perform all the Downstream activities like Assembly
preparation, accessories arrangement for step, Dispensing of raw materials
and consumables, Reconciliation of excess and unused raw materials and
consumables Buffer Preparation, Harvest Clarification, Chromatography
operation, Low pH and Intermediate depth filtration, Viral filtration, TFF
Operation and 0.2 ยต filtration.
- Operating and cleaning of downstream equipment(s) as
per standard operating procedures and EOP.
- Monitoring and process control of the specific Operations
of the Downstream.
- Maintenance of Quality records.
- Perform In-process product sampling, sample submission
and storage.
- Preparation and review of operation related documents.
- Perform room owner responsibility for the assigned DSP
area.
- Perform equipment/instrument ownership related
responsibilities related to DSP.
- Initiate Complaint Slips (work orders) for DSP related
areas and equipment.
- Coordinate with QA for line clearance.
- Maintaining process area All-time ready for Inspection/
audit purpose.
- Maintain facility and assigned zone all-time ready for
visit and audit.
- Involve and support in execution of batches as and when
required and perform error free operation as per Batch Manufacturing
Record (BMR).
- Involve in shipment of samples / final product as per
packing and dispatch record.
- Work proactively to meet all document(s) on time
closure requirement.
- Preparation of general Downstream related procedures,
protocols, risk assessment and BMRs.
- Execute the protocols related to Downstream related
activity and equipment / instrument qualification.
- Involve in Shipment of samples /final product as per
packing and dispatch record.
- Preparation and periodic revision of equipment cleaning
checklist (ECC)as ad when required.
- Execute the batch activity as per BMR and report
nonconformity to the supervisor.
- Review of executed Documents on time.
- Issuance of annexures, RM, consumables and BMRs.
- Track the work order status and ensuring timely
closure.
Involve in upstream
related activities under supervision of upstream supervisor.
Education and Experience
Education
Master’s degree/
bachelor’s degree in pharmacy, Master’s degree in Pharmaceutical Sciences.
Industry Experience
- Minimum 1 -4 years of relevant practical experience in
mAbs downstream process.
Other competencies
required for the role
- Follow the established Environment, Occupational
Health, Safety and Sustainability (EHSS) practices for safe work
environment and adhere to the highest standards of quality, integrity
& compliance for every work activity.
- Complete the assigned trainings in a timely manner and
comply with the training procedure & training calendar.
- Attend all assigned mandatory trainings related to data
integrity, health, and safety measures.
- Compliance to Current Good Manufacturing Practices and
Good Documentation Practices.
- Adherence to Standard Operating procedures, Operational
control Procedures.
- Participate in & support the trainings on
procedures, protocols, and On-the-Job activities.
- Follow the discipline of reporting structure at times
of escalation.
- Report nonconformities & deviations to the
respective supervisor(s) and/or line manager(s).
- Participate in & support for on-time initiation
& closure of deviations, investigations, CAPA and change controls.
Safety and
DI Responsibilities:
- Adhere to organizational policies & procedures on
EHSS, POSH, Data Integrity and IT security.
- Always wear the applicable PPEs and adhere to any other
Environment, Health, and Safety (EHS) requirements in the workplace for
individuals & lab/plant safety.
- Understand all necessary safety protocols and always
follow the same to ensure safety for all.
- Proactively identify near-misses & potential
incidents and communicate to supervisor and/or line manager or through the
respective web portals.
