1. Manufacturing (Packing /Granulation/Compression/Coating/Capsules/imprinting)
A) Designation:Officer/ Sr. Officer
Total experience :1 to 5 years
Qualification:B. Pharm Only
Desired Profile:
• To 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
• Co-ordination for ia/ 0Q for any new equipment/system
To 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
B) Designation : Associate/Assistant (Operator)
Qualification :B Sc./Diploma/ITI
Total experience :1 to 7 years
Desired Profile:
• Operation and cleaning of all manufacturing equipment as per current version of respective SOPS
• Maintaining the area and equipment in orderly manner as per CGMP requirements in a good state of repair and sanitized condition
Maintaining the tooling and change parts for all equipment at manufacturing
• To follow safety rules
• To perform all work related to manufacturing as per instructions of assigned
To get the required training from supervisors for CGMP and concerned SOP for operation and cleaning
2. Quality Control (OSD)
Associate/Assistant (Operator)
:B Sc./Diploma/ITI
B) Designation
:
Qualification
Total experience :1 to 7 years
Desired Profile:
• Operation and cleaning of all manufacturing equipment as per current version of respective
SOPS
• Maintaining the area and equipment in orderly manner as per CGMP requirements in a
good state of repair and sanitized condition
• Maintaining the tooling and change parts for all equipment at manufacturing
• To follow safety rules
To perform all work related to manufacturing as per instructions of assigned
• To get the required training from supervisors for CGMP and concerned SOP for operation
and cleaning
2. Quality Control (OSD)
Designation
Qualification
Total experience : 3 to 7 years
: Officer/Senior Officer/Executive
:B Pharm/M Sc./B Sc.
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
instrument's / equipment's.
• Have an exposure for the preparation of calibration & Preventive maintenance schedule of
laboratory instrument's / equipment's.
• Should have knowledge for the preparation, handling & management of working/reference
standards etc. as per requirements.
Should have knowledge for the SOP's, STP's and GTP's preparation.
• Should have QMS activities knowledge i.e. Change control, Deviations and CAPA's.
• 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, Method
Validation
Knowledge to operate various analytical instruments - UV-VIS spectrometer, KF titration,
dissolution test apparatus, Autotitrator, FTIR spectrometer, HPLC
• Knowledge to perform all quality control activities with compliance to cGxP for
instrumental, chemical and physical analysis
The candidate with good communication, inter personal skills, computer knowfedge, 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
aartig@amnealindia.com
Regards, Team HR
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