
Executive Assurance Professional
4 days ago
We are seeking a skilled Quality Assurance professional to join our organization as a Senior Officer Executive QA. The successful candidate will be responsible for ensuring the quality and compliance of our products through rigorous testing and evaluation.
">Key Responsibilities:- Coordinate, monitor, track, and participate in activities assigned for review or verification to ensure adequacy, completeness, and compliance of documents, procedure, practices, etc.
- Review Batch Manufacturing Record (BMR) and Equipment Cleaning Record (ECR) prior to release of batch in SAP HANA as per current approved procedures.
- Report Rejection Failure observation immediately and prepare and review GMP documents related to activities.
- Release Reject of material batch in SAP HANA after ensuring related relevant documents and system-related records through Trackwise about change control, deviation, Lab event, OOS, OOT closed, etc., are closed prior to approval.
- Activities related to updation transactions in SAP System, follow labelling and seal issuance procedure for materials after release, rejection of batches, involved in dispatch activity and customer COA preparation, to Verify certificate of analysis, Equipment, instrument and utilities, etc., qualification and re-qualification protocol and report review for manufacturing section.
- Coodinate with change control team for the evaluation of change controls to refer for impact assessment and to derive action items, review and closure of the change controls action items in track-wise.
- Escalate or highlight problems in QMS documents, investigations, BMR, ECR, and another document time to time.
- Involvement in training, internal audits, external audits, Regulatory and customer, Preparation and review of product quality review, APOR POR, and stated documents as per schedule, monthly report, and as and when required.
- A bachelor's degree in a relevant field such as quality assurance, engineering, or science.
- Minimum 5 years of experience in a similar role, preferably in a pharmaceutical industry.
- Excellent communication, organizational, and analytical skills.
- Ability to work effectively in a team environment and adapt to changing priorities.
- Competitive salary and benefits package.
- Ongoing training and development opportunities.
- Collaborative and dynamic work environment.
- Opportunity to work on challenging projects and contribute to the growth of the organization.
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