Associate Director - Manufacturing; Hoschton, GA

Aavis Pharmaceuticals is respected for having acquired strong capabilities for developing generic formulations and world class generic products over the years.

Associate Director-Manufacturing (Hoschton, GA) – Lead and oversee manufacturing operations for oral, sterile, API production in compliance with cGMP/FDA regulations;
Develop and implement manufacturing schedule to meet demand, minimize downtime, and ensure seamless operations;
Spearhead process improvement, lean manufacturing, and cost-saving initiatives using OOS/OOT, DPR/MIS, Laser drilling technology;
Review and approve manufacturing documentation including Commercial batch records, SOPs, and deviation reports;
Monitor production metrics and prepare performance reports for senior management;
Maintain strong focus on EHS (Environmental, Health, and Safety) compliance including CAPA;
Supervise 2 manufacturing managers.

Must have a Bachelor degree in Chemistry, Pharmaceutical Science, or Industrial Pharmacy plus 3 years experience in job offered or as Sr. Manager. As an alternative to Bachelor’s degree, Associate’s degree plus 2 years experience is acceptable. Require skills and working knowledge of OOS/OOT, Laser drilling technology, cGMP, DPR/MIS, Commercial Batch, CAPA.

Production Manager (Hoschton, GA) – Plan and manage pharmaceutical manufacturing and production activities adhering to SOPs, GMP compliance with FDA and WHO;
Review SAP entries for batch traceability, inventory accuracy, quality release, costing, and GMP compliance;
Handle QMS activities (Change Controls/Deviations/CAPA) through Trackwise ensuring data integrity, traceability and GMP compliance;
Prepare, review and approve SOPs, BMR, BPR;
Verify process robustness by preparation and execution of Process Validation Protocols;
Perform Equipment Qualification by performing IQ,OQ and PQ;
Develop New facilities and its qualification;
Review and analyze pharmaceutical process and products for quality assurance and prepare for regulatory inspections and regulatory audits;
Generate and present regular reports on production performance, quality metrics, and operational efficiency to senior management;
Supervise 2 production staff.

Must have a Bachelor’s Degree in Chemistry or Pharmaceutical Science plus 2 years experience in job offered or as Assistant Manager in pharmaceutical production. Require skills and knowledge in SAP, Trackwise, QMS, SOPs, BMR, BPR, Validation Protocols, regulatory audits, Equipment Qualification.