Aculife Healthcare Pvt. Ltd Company is a part of Nirma Group & it is one of world's largest Infusion & Injectable Company, having a State-of-the art manufacturing facility spread over 550 acres of land located near Ahmedabad, Gujarat. Aculife healthcare has global operation in more than 100 countries and it has subsidiaries in Brazil, Mexico & Vietnam. The manufacturing facility has 2 plants with FFS technology, 1 Glass injectable plant and a one dedicated R&D center equipped with advance technology and unmatched research team. Aculife has best in class quality infrastructure with the aim to assure high level of quality assurance through QBD & QAR. Aculife has developed strong footprint globally and have 1000 registrations to cater the demand of regulated and semi regulated market. Company’s domestic business is driven by 3 divisions in therapeutic area of Critical care, Parentral Infusion & Parentral Nutritions, at the same time we are the most preferred contract manufacturers for top Indian pharmaceutical companies
Hiring AGM / DGM - CQA for a Sachana facility Viramgam, Gujarat, India (35 KM away from Ahmedabad)
Qualification : B. Pharm / M. Pharm / M.Sc.
Experience :
• Minimum 15-22 years of experience in QA/CQA of Injectable / sterile/parenteral, ophthalmic and/or inhalation dosage forms as per the guidelines of regulated market
• Should worked in regulatory plant only
• Should have good experience in audit & compliances /QMS.
• Overall responsibility for audit & compliances, training development, activity of the organisation, all activity as a part of requirement of RA support from site.
• Ensure robust & effective quality compliance for continued manufacture & supply of pharmaceutical products meeting cGMP requirements.
• Effectively able to manage self-inspections, regulatory & customer audit management.
• Submission of audit compliance response to the customer & regulatory agencies within defined time frames and Tracking, monitoring & verification of action items as per the audit compliance response.
• Co-coordinating with respective cross functional team for ensuring the cGMP compliance, regulatory compliance across the site
• Providing required mentoring/ coaching to the technical staff of the site to ensure the cGMP compliance across all the operations of the site with strive for continuous improvement.
Salary : No Bar for right Candidate
Exposure : • Audits (EU/MHRA/USFDA/TGA/MCC/INVIMA/ANVISA/WHO/LOCAL GMP
Interested Candidate can email their resume to balkrishnap@aculife.co.in / manojmore@aculife.co.in
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