Home Production Packaging Sr Specialist - IPQA | Sanofi Healthcare | Toopran Mandal, Telangana

Sr Specialist – IPQA | Sanofi Healthcare | Toopran Mandal, Telangana


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With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

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Designation: IPQA Senior Specialist

Location: Toopran Mandal, Medak, Telangana

Jobs Description:

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.

LEAD competencies

  • 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.

Salary: Negotiable

Contact Details:

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