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Designation: IPQA Senior Specialist
Location: Toopran Mandal, Medak, Telangana
Visual inspection and packing
- To monitor and ensure that all activities involved in visual inspection, labeling, and packing functions are in compliance with GMP and Standard operating procedures.
- Involve in and review of Master formulae, Master packing record, protocols, reports, SOPs, Annexures, and Audit trial reports.
- To monitor the Visual inspection operator qualification program.
- To monitor that the finished product packaging profile is without any mix-ups.
- To support and ensure Qualification and Calibrations of Visual inspection, labeling, and packing equipment.
- To provide line clearance, review manufacturing data of the Visual inspection, labelling & packing batches of Batch packing records.
- To ensure and comply with the finished product time out of refrigeration and material management within Production- Packing.
- Responsible for Change controls, Deviation, CAPA, and its implementation related to Production- Packing in the PHENIX system.
- Actively participates in self-inspection and Regulatory audits.
- Support for RA submission and ensure the vendor qualifications with respect to the packing department.
- To provide the technical, GMP training as required.
- To identify, correct, and promptly report unsafe conditions, behaviors, or potentially hazardous situations.
- To Manage and provide the support to down line people to achieve the timelines/ goals.
- Performs other responsibilities delegated by Department Head as per requirement.
Medical device Packing
- To ensure adherence to EN ISO 13485 and ISO 13485 and laid down standards, Laws & Acts.
- To support LCM-MD for the establishment of a quality management system & continuous improvement.
- To handle customer complaints (investigations & related CAPAs).
- To evaluate the change control and ensure that proper change control system is followed for changes made to facility/equipment/product/process and master documents by following the change control procedure.
- To participate in the deviation/failure investigation.
- To ensure the implementation of CAPA wherever applicable. Maintain appropriate documentation related to the same.
- To coordinate for the training of the people.
- To interpret and review applicable standards and continually verifies quality management system compliance.
- To ensure proper management of SOPs & related document control system.
- To carry out and ensure the in-process quality checks.
- To review the batch record & final release of the products.
- To prepare & review the quality manual.
Knowledge, Skills & Competencies / Language
- Strong knowledge of GMPs in both domestic and international regulatory environments related to Production- Packing is required.
- Strong knowledge of ISO13485 is required.
- Strong documentation review skills
- Proven ability to lead investigations related to Deviations, Market complaints, and effective writing is required.
- Knowledge and hands-on experience in all major equipment like automatic visual inspection, labeling, packing, and serialization machines is required.
- Experience in Sterile Pharmaceutical Industry is advantageous.
- Exposure to Regulatory audits is a plus.
- Strong organizational, interpersonal, and communication skills are essential.
- The ability to communicate effectively with all levels of the organization and the ability to work effectively in an International multicultural matrix organization is strongly preferred.
- Act for Change: Embrace change and innovation and initiate new and improved ways of working
- Cooperate Transversely: Collaborate effectively with peers, stakeholders and partners across the organization to positively impact business results.
- Develop People: Take responsibility for developing one’s self and others in anticipation of future business needs.
- Language requirement: Excellent verbal and written communication skills in English are required.
Qualification: B.Sc/B.Pharma & Above
Experience: A dynamic professional with 6 plus years of experience in Production- Visual inspection and Packing or Quality Assurance Pharmaceutical industry is a plus.
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