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Aculife has been associated with the healthcare segment since over last 30 years now, which is the prime reason why the name spells unparalleled growth and absolute reliability. It also enjoys a market leader position in one of the largest economies of the world. Aculife boasts of a customer-centric vision, and is committed to offer quality products and services that maximize value to its valued customers. Aculife is one of the world’s largest sterile manufacturing facility spread over 550 acres.
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 IPQA / 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.
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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