Quality Systems Head

5 days ago

Tarapur, India Aarti Pharmalabs Ltd. (APL) Full time

Ensure quality standards for all products and manufacturing activities.To ensure the GMP compliance throughout the facility.To organize, educate for and execute activity as per the norms of Quality Assurance objective.Handling of customer audits.Releasing or rejecting APIs and Intermediates. Releasing or rejecting intermediates for use outside the control of manufacturing company.Ensure that the work force is highly motivated and aligned to the Company objectivesHandling of OOS investigation as per the current requirement.To ensure the compliance of QMS/GMP/GLPHandling of Regulatory audit and compliance (USFDA /EU /TGA /WHO /Cofepress / KFDA)Knowledge, Investigation, CAPA ,Handling of Deviation, change control, Incident, lab errorKnowledge of Risk assessments, cleaning validation/ADE/PDE, Preparation of site master file, Quality Manual, VMP handling of Data integrityQualification- electronic system / software used in QC and instrument/equipment. i.E familiar with Lims,chromeleon software And other software’s like Electronic system for BPR, DMS,Handling of Recall.Compliance report of various audits by outside agencies and customer.Vendor Audit and approval.Good knowledge of Analytical Method Validation and Verification.Review of APQR and Process verification reportTraining to all employee as per CGMP.Candidate from CDMO industry would be preferred.

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    3 weeks ago

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    3 weeks ago

    Tarapur, India Aarti Pharmalabs Ltd. (APL) Full time

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    3 weeks ago

    Tarapur, India Aarti Pharmalabs Ltd. (APL) Full time

    Position Summary:The manager – Engineering will be responsible for overseeing and managing the entire engineering and maintenance functions for Life sciences (API) operations at the Tarapur site. The role demands a strategic leader with regulated market exposure, extensive experience in handling USFDA audits, and expertise in engineering operations,...

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    3 weeks ago

    Tarapur, India Aarti Pharmalabs Ltd. (APL) Full time

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