Assistant Manager at Tata 1mg
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TATA 1mg - Assistant Manager - Category - Quality Control & Compliance (4-6 yrs)
The Job holder is required to have deep knowledge of product compliance, quality & regulatory requirements with a focus on product categories such as OTC, Health Care Devices etc.
He/She will be responsible for proactive and preventive quality assurance and control, delivering end to end result through in alignment with the third-party manufacturers of Tata 1mg.
- Scope and evaluate third party R&D and manufacturing capabilities
- Conduct third party audits and approval for internal and external compliance such as ISO, FDA, GMP, etc.
- Create quality checkboard on key parameters and ensure compliance with third party units for regular supplies as well.
- Regular operational interactions with factories/suppliers etc.
- Ensure product compliances in formulation, specifications, audits, reports, and other licenses documentation.
- Ensure Protocol batches of NPDs at respective TPUs are as per the approved formulations and quality standards
- Ensure documentation for Licenses, Audits, formulations, etc.
- Handle Cx queries related to product quality issues
- Internal Interaction - Interactions with Marketing / Packaging / Legal / Medical affairs team
- External Interaction - Existing & Prospective TPUs for R&D, Manufacturing capabilities for audits, quality, technical issues, root cause analysis etc.
- Geographical locations - Gurgaon
An ideal candidate should have:
- Bachelor's / Master's degree in Chemistry, Pharma or equivalent
- 4-6 years in OTC / Pharma / FMCG domain
- Exposure to GMP, ISO, Drugs Act, and other compliance guidelines
- Exposure to third party outsourcing methodology
- Should be well versed analytical method, product stability protocol, and key quality parameter
- Knowledge of emerging product formats and technologies
- Demonstrated track record of taking ownership of significant projects
- Strong verbal and written communication skills
- Demonstrated collaborative skills and ability to work well within a team
- Ability to work in fast paced and deadline-oriented environment
- Self- motivated with critical attention to detail