14.0 - 18.0 years

0 Lacs

maharashtra

On-site

As a Senior Manager IT Compliance, you will be responsible for ensuring the compliance of all GxP computerized systems in accordance with Sun CS QMS and regulatory requirements. Your key duties will include performing assessments of GxP computerized systems, reviewing manufacturing systems, and applying user privileges or access rights for Manufacturing and QC computerized systems. You will oversee IT compliance for Manufacturing and Lab areas by establishing and verifying security policies, conducting periodic backup & restoration activities, investigating backup failures, and verifying Windows OS policies. Additionally, you will review OEM and CSV qualification documents for manufacturing systems, conduct gap assessments of GxP computerized systems, and communicate identified gaps to the relevant teams for timely remediation. Your role will involve coordinating with teams to ensure compliance and closure of identified gaps, supporting sites in internal/external audit observations, and prioritizing remediation activities based on risk assessment. You are expected to have knowledge of Computer Software Assurance (CSA) requirements and perform proactive assessments of regulatory and internal audit observations across different sites. Your responsibilities will also include guiding remediation programs, supporting legacy/non-compliant computerized systems to achieve compliance with regulatory standards, and assisting in the implementation of global Quality-IT initiatives at sites. Furthermore, you will be accountable for maintaining key documentation of computerized systems to meet required quality standards consistently throughout their lifecycle. As a mentor, you will provide support and education to personnel in relevant areas of compliance and validation for GxP IT systems. To qualify for this role, you should hold a B. Pharm/M.Sc. degree with 14 to 18 years of experience. Proficiency in CSV and the review of GxP Manufacturing and QC systems will be essential for success in this position.,

Posted 1 week ago

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Executive IT (GMP Operations) || (Karakhadi Plant) Vadodara Alembic Pharmaceuticals

3.0 - 5.0 years

3 - 8 Lacs

vadodara

Work from Office

We are looking a skilled and motivated Executive IT (GMP Operations) with 3 to 5 years of experience for our Manufacturing Unit (Karakhadi Plant) The candidate will handling IT systems within GMP-regulated environments and support QC and Manufacturing IT operations with a strong focus on compliance, data security, and system integration. Key Responsibilities: Oversee IT GMP operations for QC and Manufacturing systems. Manage user access , data security , domain controllers , and backups . Integrate manufacturing equipment with IT systems and ensure GxP system compliance. Administer QC and Manufacturing applications like Chromeleon, Empower , etc. Operate and support SCADA, HMI , and other manufacturing systems. Ensure IT infrastructure qualification and regulatory compliance . Implement and configure Manufacturing/QC GxP systems . Maintain IT SOPs and ensure compliance during regulatory audits (USFDA, etc.). Communicate effectively and demonstrate leadership in cross-functional Candidate Profile: Bachelor's in IT, Computer Science, or related field. 35 years in pharma IT within a GMP environment . Strong understanding of 21 CFR Part 11, GAMP 5, Annex 11 , etc. Experience with regulatory audits and IT compliance. Good problem-solving, communication, and leadership skills . Interested candidates can share their updated resume at "I tcv@alembic.co.in" with the subject line "Executive IT (GMP Operations)"

Posted Date not available

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