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

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

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Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain, and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

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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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