1. Manufacturing (Packing /Granulation/Compression/Coating/Capsules/Imprinting)

A) Designation 

Officer/St. Officer Qualification B. Pharm Only

Total experience : 1 to 5 years

Desired Profile:

• Ta supervise and monitor day to day activities of processing and holding of drug product as per define and approved procedures for stability batches and commercial batches

• To maintain the areas and equipment in orderly manner as per CGMP requirements in a . good state of repair and sanitized condition To perform online documentation with respect to departmental procedures as per good

documentation:-

• To impart training of operation and cleaning related SOP to all subordinates and operators • Coordination for a/cv for any new equipment / system • Ta perform PQ for any new equipment / system

• To follow all concern departmental SOP's for day to day operation and cleaning • To handle and manage material movement as per defined procedure and approved Batch Manufacturing Record

Designation

B) Associate/assistant operator

Qualification Total experience

BSc./Diploma/II :1 to 7 years

Desired Profile:

• Operation and cleaning of all manufacturing equipment as per current version of respective


SOP

• Maintaining the area and equipment in orderly manner as per cGMP requirements good state of repair and sanitized condition • Maintaining the tooling and change parts for all equipment at manufacturing.

 -To follow safety rules • 

To all work related to manufacturing as per instructions of assigned


• To get the required training for supervisors for CGMP and concerned SOP for operation and cleaning


2. Quality Control (OSD)

Designation Qualification

Officer/Senior Officer/Executive :B Pharm/M Sc./B Sc.

Total experience 3 to 7 years

Desired Profile:


• To perform analysis Finished Product, In-process and Stability samples as per respective STPS/SOPS/Specifications/protocols & Pharmacopoeial requirement as applicable • Have an exposure on operation, calibration, Qualification and maintenance of laboratory instruments / equipments

• Have an exposure for the preparation of calibration & Preventive maintenance schedule of laboratory instruments / equipments.

• Should have knowledge for the preparation, handling & management of working/reference standards etc. as per requirements, • Should have knowledge for the SOP, STEPs and GTPs preparation • Should have OMS activities knowledge is. Change control, Deviations and CAPAs, • Responsible for the preparation and standardization of volumetric solutions/reagents and to maintain related documents.

• Specific exposure on XRPD, LCMS, GCMS, ICPMS, AAS, Method development • Knowledge to operate various analytical instruments - UV-VIS spectrometer, KF titration,Validation

Method

dissolution test apparatus, Autotitrator, FTIR spectrometer, HPLC

 • Knowledge to perform all quality control activities with compliance to CGMP for


instrumental, chemical and physical analysis

The candidate with good communication, Interpersonal skills, computer knowledge, exposure to

CGMP/GLP Knowledge and understanding of regulatory requirements are essential (Preferred 21


CFR compliance Only Interested & Relevant candidates may share their updated profile with

Only Interested Candidates Share Thaire resume at

aartig@amnealindia.com


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