GlaxoSmithKline Pharmaceuticals Ltd. (GSK Rx India) is one of the oldest pharmaceuticals company and employs over 5000+ people. Globally, we are a £ 27.4 billion, leading, research-based healthcare and pharmaceutical company. In India, we are one of the market leaders. At GSK, our mission is to improve the quality of life by enabling people to do more, feel better and live longer. This mission drives us to make a real difference to the lives of millions of people with our commitment to effective healthcare solutions.
Post: Executive- Operational Quality
Job Description
- To ensure release of bulk and finished products, meeting the statutory and QMS requirements, to market.
- To work in shifts as per the requirement.
- To verify line clearance in the shift
- To have adequate quality oversight in warehouse and engineering department.
- To ensure that the activities on shop floor are in compliance with regulatory and QMS requirements.
- Review Master BMR / draft MFR of products manufactured and packed in area of operation as per regulatory requirements and SOP.
- To complete the QMS training in time and ensure the compliance with QMS in your area of operation.
- To carry out the gap analysis as per the requirement.
- To support L-2 Audits and conduct Self Inspection.
- To ensure compliance to all audit observations in a time bound manner.
- To have control on master documents like, MFR, BMR,PQS etc. in Quality Assurance for easy retrieval and traceability.
- Ensure Trend Analysis of the products in your area is done as per SOP
- Handling of BPCS System related to batch release.
- Review of SOPs and ensure SOPs for area under control are valid and meets all regulatory and QMS requirements
- To conduct Periodic Product Review as per the approved schedule. Inform timely, the findings in PPR and ensure closure of the same.
- To conduct initial assessment of change control raised in area of operation.
- Support training, validation, Deviation RCA investigation by actually participating in 6 step process.
- Carry out in process check randomly in area of operation & document it
Candidate Profile
- Candidate must possess at least a Bachelor of Pharmacy in Pharmacy/Pharmacology or equivalent.
- At least 3 year(s) of working experience in the related field is required for this position.
- Preferably Junior Executives specializing in Quality Control/Assurance or equivalent. Job role in Quality Control/Assurance or equivalent.
Additional Information:
Experience: 3-5 years
Location: Nashik
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: QC/QA
End Date: 7th Novemer, 2014
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