QA Manager
2 days ago
Ascent Finechem is a young, high-growth manufacturer of fine and specialty chemicals with a focus on Anisic Aldehyde and its derivatives. Since 2004, Ascent has grown into a leading supplier of key starting materials (KSMs), API intermediates, and other specialty chemicals to pharmaceutical manufacturing companies across the globe.
We're looking for a Quality Assurance Manager - the ideal candidate is a critical thinker who will proactively improve the quality systems of the company through internal audits, participation in process improvement programs, and interaction with key partners to obtain constructive feedback.
Job Description / Responsibilities
- Establish and maintain quality management system (QMS) across all plant functions
- Maintain GMP standards in production, warehouse, and QA/QC area, and ensure documentation of and employee training for GMP practices.
- Conduct regular internal and external audits in accordance with customer audit agreements, industry certifications, and high QA standards and compile detailed reports of findings.
- Approve vendors for raw materials and packing materials
- Fill out customer/vendor questionnaires
- Plan and execute holding time studies and use those results to make decisions regarding final packing and retest dates.
- Prepare and review specifications, MOA, BMR, BPR, APQR, and controls as per standard operating procedures (SOPs).
- Approve finished products for sale.
- Handle deviations, change controls, and market complaints per SOP, including reviewing OOS and investigating via root cause analysis, taking corrective and preventive action, and following through on compliance till the final approval stage.
Must-have Qualifications
- MSc. Organic Chemistry or B.Pharm
- 5-10 years of relevant work experience doing QA in API/bulk drug industry only
- Good communication required for external and internal audits; professional fluency in English required.
- Highly organized with excellent attention to detail
- Note: no formulation industry experience please
Location
- Vatva, GIDC
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