Audit and Compliance Manager (GMP Auditor)
FinOrion Pharma India Pvt. Ltd. is looking for an Audit and Compliance Manager (GMP Auditor) in Quality Assurance department. In this position you will be based in Mumbai.
Description of position
- To evaluate and ensure the quality level of Intermediate material, Active Pharmaceutical Ingredient & Excipient, Finished Products manufacturer (sterile/ non-sterile), Packaging Material Manufacturer by conducting GMP audits including timely audit report preparation, and follow-up for CAPA
- To arrange and co-ordinate audits in India and out-side India as per schedule
- To participate to audit program creation and follow-up 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
Description of unit
FinOrion Pharma India Pvt. Ltd. (http://www.orionpharma.in) is a wholly owned subsidiary of Orion Group. A presence in India provides an opportunity for Orion Group to strengthen the business relationship with the current partners and support the head quarter in various office activities. The India office focuses mainly on Global Operations and R&D activities.
Global operations (formerly known as supply chain) is one of the core area of operations in Orion's India office. This office is involved in procurement of in-licensed formulated products and pharmaceutical ingredients for in-house manufacturing in Finland. The Packaging Technology team is involved in creating and managing artworks for both in-licensed and in-house manufactured products. The Quality Assurance team is involved in auditing our partners globally to ensure cGMP compliance.
CPD & LCM India (Pharmaceuticals and Regulatory Affairs teams) supports the product life cycle management, maintenance of marketing authorizations, various other documentation requirements and supports activities such as biostatistics, programming and medical writing tasks for regulated markets. The Creative Design team in India supports digital/graphic designing activities.
Orion Corporation (https://www.orion.fi/en) is a globally operating Finnish company that develops, manufactures and markets human and veterinary pharmaceuticals, active pharmaceutical ingredients. The company employs more than 3,000 professionals in different countries. In Finland, Orion is the leading company as a manufacturer and marketer as well as in R&D of pharmaceuticals. With strong engagement in the promotion of healthcare, Orion has been building well-being for 100 years. Our ambition in the far-sighted research activity is to introduce novel, innovative medicinal treatments for global markets.
- An excellent opportunity to work in an inspiring and important role in the area of GMP Auditing
- Great opportunity to become part of the wholly owned subsidiary of globally operating Orion Group
- Possibility to utilize your own strengths with the support of professionals
- Flexible, high spirit working environment where your skills are appreciated
- Hybrid Work Policy (In a week - 3 days work from office and flexibility to work remotely for two times).
- Good work-life balance
- Clear, transparent processes and responsible supervisors are our benefits to the personnel
- Masters degree in Pharmacy / M. Sc. from a reputed College / University
- 8 - 10 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
- Candidate Information Form: https://forms.gle/45rjK7bpjHZ56sEZ7
Submit your application as soon as possible and latest by November 30, 2023.
When you submit your application you agree with FinOrion Pharma India Pvt. Ltd. GDPR information notice.