Audit and Compliance Manager
Audit and Compliance Manager
Posted on :
13-04-2025
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1 Vacancy
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Job Description
Description
Roles and Responsibilities
- To evaluate and ensure the quality level of Intermediate material Active Pharmaceutical Ingredient & Excipient Finished Products manufacturer (sterile/ nonsterile) Packaging Material Manufacturer by conducting GMP audits including timely audit report preparation and followup for CAPA
- To arrange and coordinate audits in India and outside India as per schedule
- To participate to audit program creation and followup and maintenance of vendor status
- To be responsible for conduction of audits of Contract Manufacturing and Contract Research Organizations and follow up for the compliance including compliance audits
- To do the vendor qualification for Raw Materials (API excipients intermediate) Packaging Material manufacturer and continuously monitor the quality of the products supplied by them
- To conduct the various audits as per the requirement from R & D Department and Medicinal Chemistry department from time to time
- To conduct the triggered audits of the basis of the quality mishaps such as complaints regulatory warning letters OOS recalls and returns if any for contract manufacturers and other vendors
- To assist and support in the various projects undertaken by Head quarter Finland from time to time
- To maintain liaison between the various vendors and Orion Finland
- To execute of goals and schedules in own area of responsibility as agreed
- To take the other responsibilities from time to time as suggested by Higher Management
Primary Skills required
- 810 years experience in Pharmaceutical Quality Assurance (preferably EU/ US markets) and/ or Production including substantial experience of Vendor (GMP) Auditing
- Candidate having hands on experience with working at sterile manufacturing facility/ in Chemical Laboratory & or Microbiology will have an added advantage
- Experience of working in ERP/ SAP and TrackWise system
- Task oriented with learning attitude. Quick learner
- Ability to work in team and flexibility to adapt to change
- Good English communication skills (both verbal & written). Good Interpersonal Skills.
- Ready to take additional responsilities from time to time
How to apply and additional information
Instructions on how to apply Please fill Candidate Information Formon & email your CV to
Required documents CV/Resume
Application deadline 28.02.2025
Required Experience:
Manager
Employment Type
Full-Time
Key Skills
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