SYNGENE Hiring Career Opportunities: Senior Executive M.Sc Chemistry Apply Now
Job Purpose
Efficiently review the documents
pertinent to batch release and ensure compliance to laid down procedures.
Key Responsibilities:
Review of executed batch manufacturing
records, batch packing records, batch cleaning records.
Review and ensure closure of QMS
records related to the batch and where open, with due justification, before
release of the batch.
Review of audit trail records of
the GMP computerized systems as part of the batch release.
Ensure online trending of critical
process parameters, critical in-process controls, critical quality attributes
and report the deviations to the normal operating ranges.
Ensure the quality management
system documents are appropriately addressed prior to release the batch.
Responsible to verify the weights
of the dispatch material as per the batch packing record.
Verify the customer agreements for
compliance and ensure the agreements are followed all the time.
Responsible to follow the Good
documentation practices, Data integrity principles, company policies and
regulations.
Ensure collection of requisite
quantity of retention samples
Release of the batch in accordance
to laid down procedure.
Review of specifications, manufacturing,
packing, quality control records pertinent to the batch
Review of quality agreement
pertinent to the client for whom the batch/es are manufactured.
Review of QMS documents (change
control, deviation, OOS, LIR, Investigations reports, CAPA etc.) related to the
batch.
Ensure closure of the QMS
documents, as applicable before release of the batch
Ensure online trending of critical
process parameters and critical quality attributes related to the product.
Ensure collection of requisite
quantity of retention samples
Release of the batch in accordance
to laid down procedure.
Evaluate and clear the line for Manufacturing,
Packing, Quality Control testing as per approved procedures
Ensure assurance on execution of
manufacturing, packing, quality control testing, and Engineering &
Maintenance processes as per laid down procedures
Ensure assurance of online
documentation of activities
Ensure assurance of investigation
of root cause and implementation of CAPA in the event of failures / observed
non-compliances during internal and external audits
Evaluate effectiveness of
implemented CAPA.
Educational Qualification:
M.Sc Chemistry
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