Quality Assurance
4 days ago
Roles and Responsibilities
- Responsible to design validation/ qualification strategies.
- Responsible for validation /qualification of processing equipment's, cleaning equipment's and testing equipment's on time.
- Responsible to review & approve of validation /qualification protocols and reports.
- Responsible for day to day validation planning and execution activity.
- Planning, Execution & Participation of aseptic process simulation activity.
- Responsible for process validations, hold time studies, thermal studies, transport validation, filter validation etc but not limited.
- Responsible to design, review, approve and implementation of departmental standard operating procedures.
- Responsible to review, approval and authorization of all standard operating procedure of the site.
- Responsible to approve specifications, standard test procedures and analytical work records.
- Responsible to approve master batch manufacturing records and master batch packing records.
- Responsible to integrate all the standard operating procedures and to design a quality system to prevent and correct quality related subjects.
- To approve quality management system documents i.e. change controls, deviations, incident reports, out of specifications, out of trends, non-conformance reports, market complaints, product recalls, returned goods, corrective and preventive action reports.
- To handle the market complaints and to participate in product recall.
- Responsible to perform vendor audit & approve vendor for raw materials, packing materials, contract manufacturing facilities & contract testing laboratories.
- Responsible to finalize annual GxP / Technical training planner as per requirement and Its Plan, execution as planner.
- Responsible to conduct internal audit /self-inspection to ensure compliance to cGMP and other regulatory requirements.
- Responsible for regulatory & customer audits preparation, execution and its compliance.
- Responsible to review of annual product quality review, environment monitoring trends & water systems testing trends.
- Responsible to co -orientate with internal as well as external department personnel to maintain the CGMP environment
- Responsible to update & maintain online departmental documentation.
- To ensure supply of products and service are having acceptable standards.
- To approve and authorize technical agreements from customer and outside party.
- To approve & authorize protocol received from outside party.
- Responsible to approve and authorize destruction of rejected materials/batches.
- Responsible to coordinate with regulatory department for submission of dossiers and documents to regulatory department.
- Responsible to make the management aware of any deviation/non-compliance or any other quality related issues during validation/ qualification & processing.
- Responsible to inform top management for future requirement of departmental up-gradation necessary for the growth of organization and to meet regulatory requirement.
- To ensure the implementation of quality risk management procedures.
- To ensure that proper implementation of data integrity policies.
- Responsible to approve SMF, VMP, quality manual and project validation documents & release the batch after the compliance with the specifications in absence of Senior Manager QA.
Desired Candidate Profile
Candidate Should have experience in Injectable plant only
Good Verbal & Written skill
Proficient in Ms office/Excel & Word
Perks and Benefits
Medical Reimbursement
Subsidized Accommodation for Bachelors
Professional Development
Paid time off
Work/life Balance
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