Roles and responsibilities
- Work and coordinate with Sami Labs headquarters and regional office to facilitate, monitor, review and improve the performance and productivity of the outsourced production entities and peripheral factories.
- Work and coordinate with appointed Certification Agent to ensure product produced and distributed is safe, consistent and meets or exceeds Sami Labs quality requirements.
- Assures the execution of Sami Labs Quality Systems at all manufacturing facilities.
- Assures execution of procedures and processes critical to quality systems
- Work with outsourced production entities, including contracted labs or auditors and peripheral factories to develop, execute and evaluate quality and production trainings.
- To be reviewed at performance measurement scale of weighting suggested.
- Work with headquarter Manufacturing & BD team, outsourced production entities, peripheral factories and input suppliers for effective execution of production plan and to meet the monthly product delivery schedule as per business requirement i.e. product demand/ PO
- Effectively and timely install quality measures with outsourced production entities and peripheral factories to accelerate the level of production maturity and quality compliances.
- Effectively assess production capabilities (equipment and human resources) of outsourced production entities and plan strategically to pace manufacturing schedules
- Effectively install a system to reconcile RM/ PM inventory and yield losses and work on remedies for continual improvement on the same.
- Work and coordinate, outsourced production entities and peripheral factories to establish a regular performance review mechanism
- Supplier Quality ingredients, components and finished goods.
- Assures supplier qualification through execution of companys standard protocol.
- Provides on-site, hands-on site oversight of production, inspections, approvals at suppliers and contract manufacturers.
- Supports best practices for supplier selection through utilization of Qualified Supplier Matrix.
- Assures proper Transfer of Technology in order to result in product that meets defined product requirements regardless of production site.
- Work and coordinate with headquarters to manage collaborative testing for laboratory or monitoring system qualification.
- Regulatory Information Gathering and Alignment
- Interpret and implement, where appropriate, regulatory, compliance information and requirements from FDA, FSSAI, AYUSH, HALAL etc..
- Take initiatives and co-work with headquarters to comply with and complete registration processes.
- Product Issue Feedback and Management
- Partners with HQ Quality Systems, Product Safety, Regulatory, Purchasing and manufacturer to manage product issues. Work with headquarters to systematically gather information, investigate and determine actions needed to support resolution of product issues.
- Functional Development
- Work with headquarter to advocate for continual improvement initiatives including CAPA, ISO and PDCA.
Salary: Not Disclosed by Recruiter
Industry:Pharma / Biotech / Clinical Research
Functional Area:Production, Manufacturing, Maintenance
Desired Candidate Profile
UG:B.Pharma - Pharmacy, B.Tech/B.E. - Any Specialization, Chemical, B.Sc - Any Specialization, Bio-Chemistry, Chemistry
Sami Labs Limited
"The vision of a research scientist and a passionate entrepreneur takes on social and commercial expressions." This, in short, explains the genesis and growth of Sami Labs"
Founded by Dr. Muhammed Majeed, an internationally acclaimed scientist and entrepreneur in the area of "Alternative Medicine", Sami Labs Limited is a research-oriented multinational health science company and a leading producer of nutraceuticals, cosmeceuticals, standardized herbal extracts, fine chemicals, specialty chemicals, and probiotics. The Government of India honored Sami Labs Limited with the National Award for Quality Products (Basic Drugs) in the year 1994 and the Prestigious DSIR award in the year 2002. The company is endowed with independent research divisions including Natural drugs, Phytochemistry, Synthetic Chemistry, Tissue Culture, Biotechnology, Analytical R&D, Biological Research, Microbiology, and Formulations R&D, all of which coordinate in a synergistic work model to create products meeting international standards.
With its 120 world-class scientists who are working tirelessly to discover and develop standardized natural ingredients that make life better, over 5,000 acres of contract farming and commitment to sustainable development, Sami Labs Ltd. continues to develop innovative, patented nutraceutical and cosmeceutical products for its clients.
Sami Labs has close to 200 US and International patents awarded and several more in the process, all products manufactured by Sami Labs are formulated in accordance with the global standards.
A solid foundation for dreams - Sami has seven state-of-the-art manufacturing facilities across the globe equipped with a continuous extraction plant with 30-40 tones extraction capacity of herbal raw material per day. An important aspect of the closed solvent recovery system in this facility is that the environmental pollution due to the release of solvent vapors is diminished. All the facilities are accreditated with ISO22000:2005, FSSAI. Sami Labs is the first company which installed a Super Critical Fluid Extraction facility in collaboration with IIT Bombay with Indian technology. In this technology, only liquid carbon dioxide is used in its supercritical stage as an extraction solvent, which is inert and eco-friendly and it is completely recycled and nothing is let out. To its credit, Sami has over 30 national and international awards.
Contact Company:Sami Labs Limited
Address :19/1 & 19/2, Peenya Industrial AR 1 MN 2 PH, BANGALORE, Karnataka - 560058,India