Opportunity for M.Pharm or B.Pharm as Associate Manager at Syngene International

Syngene International is one of India’s premier contract research and manufacturing organizations in providing customized service. Our services encompasses all across discovery chain: early stage discovery, process development, cGMP manufacturing and formulation development both in the small molecule and novel biologics area. Based in Bangalore, Karnataka, the Company is situated in a 90 acre Special Economic Zone with over 100000 sq. mt of built up facilities.

Post : Associate Manager

Job Description
Job Purpose
Responsible for Supervision, documentation, upkeep, facility maintenance, cGMP compliance for packaging development and packaging operations at formulation manufacturing facility for human and animal health for oral solids, injectable and semisolids dosage forms.

Primary Job Responsibilities
• Experience in Pharmaceutical Packaging and Operations & Manufacturing, Serialization Track & Trace,
• Knowledge of Packaging development, packing process validation, finalization of packaging change parts, evaluation of Packaging materials, and machines.
• Change parts qualification, new packing equipment qualification.
• Technical knowledge and hands on experience of operating of Blister packing machines like BQS, IMA PG, CAM NMX etc.
• Technical knowledge and hands on experience of operating Bottle pack machines.
• Technical knowledge and hands on experience of operating Cartonator - IC 150(IMA PG), CP150.
• Technical knowledge and hands on experience of operating Printers such as Image, Videojet, Wolke printers.
• Technical knowledge and hands on experience of operating Sachet/pouch packing.
• To ensure Quality and compliance and facility readiness for client visit/ audits.
• To ensure logbooks update, log sheets tracking and review of facility documents.
• Experienced in regulatory compliance requirements (e.g. USFDA, MHRA, WHO, TGA).
• Initiation of Change control for procedural revisions, changes in facility.
• Procurement activity for consumables, instrument & equipment qualification.
• Preparation of URS, review of DQ, IQ, OQ. Preparation & execution of PQ.
• To ensure preparation & revision of SOP/IOP/EOP/ECC
• Supervision, execution, planning & execution of clinical batches & registration batches manufacturing and packing activities.
• To ensure cGMP training on a scheduled manner to all concerned personnel.
• To ensure compliance to quality system procedures & documentation as per organizations requirements.
• Hands on experience knowledge of Track-wise, SAP and Documents management system.
• People management, Learning & training:
* To review contract people daily work.
* To ensure training to all on procedures.

Secondary Job Responsibilities
• To ensure and implement procedures to target Zero Incidents.
* To ensure preparation of Risk Assessment
* To ensure proper Housekeeping and to circumvent EHSS Violations.
* PPE compliance.
• To support Project Execution.

Candidate Profile
• M.Pharm or B.Pharm having 9-12 years of experience in pharmaceutical packing development and packing operations is required. Diploma in packaging operation from reputed packaging institutes will be an added advantage.
• Experience in Pharmaceutical Packaging and Operations & Manufacturing, Serialization Track & Trace.
• Knowledge of Packaging development, packing process validation, finalization of packaging change parts, evaluation of Packaging materials, and machines

Additional Information
Qualification : M.Pharm or B.Pharm
Experience : 9-12 years
Location : Bangalore
Industry Type : Pharma/ Healthcare/ Clinical research
Req Id : 7742
End Date : 20th February, 2020