Formulation DQA - 5 To 10 Years Experience Requirement

MSN Group

5 - 10 years

6 - 11 Lacs

hyderabad

Posted:4 days ago| Platform:

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Skills Required

capa oos / oot investigation bpr bmr fdqa market complaints gdp process validation gmp deviation

Work Mode

Work from Office

Job Type

Full Time

Job Description

Experience:
5 to 10 years in QA
.
Qualification M Pharm or B.Pharm

Review and approve
development protocols
,
reports
, and
technical documents
for formulation, analytical, and process development.
Ensure development studies are conducted as per
Good Documentation Practices (GDP)
and
QMS procedures
.
Oversee
batch manufacturing records (BMR/BPR)
and
analytical data
for R&D and scale-up batches.
Participate in
formulation and analytical strategy meetings
to ensure quality alignment.
Development SOPs and related quality documents.
Master formula records and batch manufacturing records.
Analytical method validation and verification protocols.
Evaluate and assess
changes
raised during development (e.g., formulation, process, analytical method, equipment).
Review
deviations, OOS/OOT investigations
, and ensure timely closure with robust
root cause analysis (RCA)
and
CAPA
implementation.
Support trending and effectiveness checks for CAPAs related to development operations.
Review
TT protocols and reports
for process and analytical method transfer.
Ensure
data integrity and traceability
of transferred methods and processes.
Coordinate with receiving site QA/QC for
TT documentation and verification
.
Participate in
pre-approval audits / readiness checks
for technology transfer batches.
Support quality evaluations and audits of
CMOs, CROs, and material vendors
.
Review
quality agreements
and ensure quality compliance for outsourced activities.
Provide DQA inputs for CMO qualification and ongoing quality monitoring.
Ensure adherence to
data integrity (ALCOA+)
principles in all development documentation.
Conduct
internal audits / self-inspections
of development labs for compliance verification.
Provide training to R&D and analytical staff on
QMS and documentation practices
.
Support QA inputs for
CMC documentation
in regulatory submissions (IND, NDA, ANDA, IMPD).
Ensure that
QMS elements (Change Control, Deviation, OOS, CAPA)
are effectively applied in the development area.
Support
quality risk assessments
(QRA) and
QbD initiatives
during formulation design.

Identify process or system gaps in development operations and initiate improvement projects.
Participate in
cross-functional quality initiatives
(e.g., method lifecycle management, data integrity strengthening).
Support
knowledge management
and lessons learned documentation after development projects.
Preferred Skills:
Knowledge of ICH, FDA, EMA, WHO, and ISO guidelines
Exposure to QbD, risk management, and data integrity systems
Good communication and writing skills

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