SYNGENE Career Opportunities: Senior Executive - Quality Assurance - Chemical Development M.Sc., M. Pharm Apply Now
Job
Description:
Key
responsibilities:
Should be
aware of QMS system to small molecule API facilities and participates in
Initiation, review and approval/ rejection of Change controls, deviations,
& Risk assessments OOS investigation, Client’s or regulatory audit
co-ordination, Audit CAPA initiation and follow-up and closure and Preparation,
Review and approval of Quality agreement, APQR.
To comply with all the regulatory audits like USFDA, PMDA, WHO, EUGMP,
TGA and other regulatory agencies. All
the time ready for compliance with regulatory and Client’s expectations.
Responsible
for Preparation, Review and approval VMP, Validation protocols and report
(Process, Analytical and cleaning) and monitoring commercial validation batches
and training for the execution of the validation. Taking independent responsibility of Process
and Cleaning validation of specific Clients requirements in line with FDA, APIC
& other regulatory guidelines on process, analytical & cleaning
validation. To attend regular tele conic
and support Client’s expectations, provide on time support to meet the specific
timelines. Must be having very good
skill of assessing, writing and finalization of investigations on any such
process, cleaning and analytical validation requirements in line with
regulatory expectations.
Responsible
for preparation & review of master/ Executed BMRs, PDRs, line clearance,
dispatches followed by batch release. Implementation of Quality management
system in the Small molecule API/ intermediate facility.
Knowledge of
new facility commissioning and Qualification, computerized system validation,
routine qualification and validation, activity. Support to the calibration and
preventive maintenance activity. Well-versed with preventive & breakdown
maintenance, calibration, HVAC systems, utilities followed by any activities
pertaining to projects and Engineering and maintenance. Expertise in the specific guidelines like EU
Annex 11, 21 CFR Part 11, GAMP 5 and expert in conducting the gap analysis of
computerized systems.
Aware of
Quality system in the purchase and warehouse, participating in warehouse
activities including receipt verification, line clearance, investigations,
review and approval of procedure for small molecule drug substance.
Vendor &
Warehouse management, Cleaning & Process validation expertize, awareness of
Quality management system as per current guidelines.
Follow
environment, health, and safety (EHS) requirements always in the workplace
ensuring individual and lab/plant safety.
Attend
training on environment, health, and safety (EHS) measures imparted company.
Educational
Qualification: M.Sc., M. Pharm with
Total Quality Management (TQM) or equivalent.
Technical/functional
Skills:
The candidate
must be aware of Quality management system, process & cleaning validation,
exposure of current quality guidelines, good knowledge of DI perspective,
vendor & warehouse management, IPQA skills followed Equipment
qualification, Calibration related to Engineering & Maintenance supports.
Good investigation writing skills & good English speaking & writing
skills. Knowledge of CSV, EHSS is also
preferred.
Experience:
4-6 years
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