Executive Sr Executive Pharmaceuticals

3 months ago

Mumbai, India Lifelancer Full time

About thejob

FinOrion Pharma India Pvt.Ltd. is looking for an Executive / Sr. Executive Pharmaceuticals inPharmaceuticals department. In this position you will be based inMumbai.

Description OfPosition

Responsibilities:

  • Writing of Product Quality Review (PQRs) forown production products ensure its timelyapproval.
  • Preparation and review of otherdocuments related to PQRs.
  • Requesting followupand tracking of PQR related data.
  • Review ofexternally supplied PQRs related coordination and follow up withvendor and other stakeholders.
  • Reviewing andcommenting on change controls deviations temperature excursionsstability data process validation documents troubleshooting etc.for ESO products.
  • To evaluate dossiers andsuggest the additional requirements (if any) for probable newmarket.
  • Responsible for planning stabilitystudies writing and/or review of stability protocols reports andpreparation of technical documents in CTDformat.
  • Coordinate and follow up stabilitystudies at CROs/CQC
  • Writing and/or reviewingof process validation technology transfer study batch documentationfor own products
  • Write/check/reviewpharmaceutical documents as per regulatoryrequirements.
  • Write documents into Orions ITsystems.
  • Preparation and maintenance oflists/documents/records and archiving at appropriateplace.
  • Coordination with other departments /partners
  • Achievements of responsibilitieswithin the agreed timelines
  • To assist theoverall working of Indian Pharmaceutical team
  • Other tasks appointed by Supervisors
  • Note: Wedo not have own laboratories in India

Description Of Unit

FinOrion Pharma India Pvt. Ltd. () is a whollyowned subsidiary of Orion Group. A presence in India provides anopportunity for Orion Group to strengthen the business relationshipwith the current partners and support the head quarter in variousoffice activities. The India office focuses mainly on GlobalOperations and R D activities.

Global Operationsis one of the core areas of operations in Orions India office. Thisoffice is involved in procurement of inlicensed formulated productsand pharmaceutical ingredients for inhouse manufacturing inFinland. The Packaging Technology team is involved in creating andmanaging artworks for both inlicensed and inhouse manufacturedproducts. The Quality assurance team is involved in auditing ourpartners globally for ensuring cGMP compliance.

CPD LCM India (Pharmaceuticals and Regulatory Affairsteams) supports the product life cycle management maintenance ofmarketing authorizations various other documentation requirementsand supports activities such as biostatistics programming andmedical writing tasks for regulated markets. The Creative Designteam in India supports digital / graphic designingactivities.

Orion Corporation () is aglobally operating Finnish company that develops manufactures andmarkets human and veterinary pharmaceuticals active pharmaceuticalingredients. The company employs more than 3000 professionals indifferent countries. In Finland Orion is the leading company as amanufacturer and marketer as well as in RD of pharmaceuticals. Withstrong engagement in the promotion of healthcare Orion has beenbuilding wellbeing for more than 100 years. Our ambition in thefarsighted research activity is to introduce novel innovativemedicinal treatments for global markets.

We offer

  • An excellent opportunity to work in aninspiring and important role in the area ofPharmaceuticals
  • Great opportunity to becomepart of the wholly owned subsidiary of globally operating OrionGroup
  • Possibility to utilize your ownstrengths with the support of professionals
  • Flexible high spirit working environment where your skills areappreciated
  • Hybrid Work Policy (In a week 3days work from office and flexibility to work remotely for twotimes).
  • Good worklifebalance
  • Clear transparent processes andresponsible supervisors are our benefits to thepersonnel

Requirements

  • Bachelors / Masters degree in Pharmacy from areputed College / University
  • Minimum 4 yearsexperience in Formulation RD activities in global Pharmaindustry
  • Confirmed knowledge of EUrequirements and ICH guidelines
  • Candidatehaving interest and/or experience in pharmaceuticals documentationor any relevant pharmaceutical formulation / manufacturing relateddocumentation will be preferred.
  • Practicaldevelopment skills from the laboratory to the production scaleconcerning diverse types of formulations (tablets capsules liquidsetc.) will be considered as an addedadvantage.
  • Proactiveness and problem solvingabilities
  • Fluency in oral and writtenEnglish
  • Task oriented with learning attitudeand Teamwork skills
  • Confirmed skills ofMicrosoft Office isessential

Lifelancer ( ) is a talenthiring platform in Life Sciences Pharma andIT. The platform connects talent with opportunities in pharmabiotech health sciences healthtech data science and ITdomains.

Please use the below Lifelancer linkfor job application and quickerresponse.

/jobs/view/d42fef3137bb60ca0bf3dcab05ff1504

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