Baxter International Inc. develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide. Baxter had 2012 sales of $14.2 billion and has approximately 50,800 employees.
Post: Executive QA
Job Description
1. To perform day-to-day activities of the plant document center viz. document control, batch document review, critical system monitoring and finished product release are efficiently completed.
2. Preparation of plant SOP’s , Review of Batch Manufacturing records, MFM’s, P & ID’s, Product Dossiers, Bulk/RM/PM/FG Specifications, Manuals. Responsible for archival of all the important documents and absolution of the same as per the requirements.
3. Perform SOP distribution and absolution along with other Master documents and perform the uploading of documents in BPLM (Baxter Product Life-Cycle Management).
4. Perform in process quality assurance activities and IPQA checks for component Side manufacturing in any assigned shift operation
5. Responsible for review of batch documents and conducting DPM-QA activities before Releasing the products to the market.
6. Carry out Core QA activities and maintain the records updated and in auditable form like Exception/Non-conformance documents, Change control, Document Change control, MDR, Sterilizer aberrant cycle, Critical work orders and rework documents.
7. To help in preparation and implementation of Certificate of compliance in association with Assistant Manager and Manager QA
8. Handling of complaint as per SOP and assist Assistant Manager Quality of complaint investigation
9. Responsible and monitor the day to day QA activity of component operation i.e. Extruder / SAP
10. Maintain confidential ability; ensure safe custody and efficient handling of company documents and Material.
11. To prepare and review the validation / Qualification protocols and conduct validation activity as per approved protocol
Candidate Profile
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required.
N/A: Intern or Co-op
Competencies:
1. Good knowledge of GMP regulations and regulatory requirements.
2. Oral, written communication skills
3. Able to locate and eliminate the source of problem in any flow of work.
4. Able to meet organizations goals, get job done.
Additional Information:
Location: Waluj, Maharashtra
Job ID: 40722
Industry Type: Pharma/Biotech/Clinical Research
End Date: 30th June, 2014
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