Responsible for overall QA function compliance with various regulatory
guidelines and standard operating procedures in practice at the site.
Review and monitor quality systems and provide guidance to team for
implementation.
Responsible for Review and approval of Batch Manufacturing Record (BMR) &
Batch Packing Records (BPRs).
Responsible for preparation, review and Approval of Media Fill Protocol,
Report.
Responsible for assurance of cleaning, sterilization and aseptic
manipulations of components.
Responsible to implement, monitor and Processing of finished products at
every stage as per defined norms, as per the master BMR and BPR, implement
system for testing and release or reject of finished products by proper
approvals.
Responsible for sampling verification and coordination during validation
studies (process / cleaning validation).
Responsible for commercial batch release to market.
Responsible for Quality Assurance activities in process.
Responsible for preparation, Review and implementation of SOP's
Identify potential problems and co-ordinate resolution to issues.
To develop and implement systems for handling product complaints and
evaluate these complaints to avoid the re-occurrence in and maintenance of
necessary records thereof.
Responsible for the assessment and approval of Change Control, Deviation,
CAPA, Investigation etc.
To implement a system for product Recall and to take action on product
recalls, investigate the reasons and report, whenever required.
To ensure environmental (Active, Passive, Surface & Personal) monitoring
trends.
To ensure batch documents are reviewed as for cGMP records.
Lead and facilitate for audit and compliance at site. Enhance and reinforce
quality culture to ensure site in at continued state of compliance and
readiness.
Participation in management review of process performance, product quality
and quality management system and advocating continual improvement.
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