Accuprec Research Labs Pvt. Ltd. Job Openings for QA / Regulatory Affairs / IT Department

About Us

Accuprec Research Labs Pvt Ltd. is FDCA approved, NABL accredited and ISO 9001:2015 certified
CRO. Head Quarter of the CRO is located at Ahmedabad and branch offices at Canada and USA.
Accuprec provides all type of Pharmaceutical testing solutions to its domestic and MNC clients.

Accuprec requires below mentioned staff

1. Department: QA

Role: 𝐑𝐞𝐬𝐞𝐚𝐫𝐜𝐡 𝐀𝐬𝐬𝐨𝐜𝐢𝐚𝐭𝐞 (𝐐𝐀) / 𝐒𝐫. 𝐑𝐞𝐬𝐞𝐚𝐫𝐜𝐡 𝐀𝐬𝐬𝐨𝐜𝐢𝐚𝐭𝐞 (𝐐𝐀)
Qualification & Experience: 𝐌.𝐒𝐜./𝐌.𝐏𝐡𝐚𝐫𝐦 𝐰𝐢𝐭𝐡 𝟐-𝟕 𝐲𝐞𝐚𝐫𝐬 𝐨𝐟 𝐞𝐱𝐩𝐞𝐫𝐢𝐞𝐧𝐜𝐞

Job Description

• Review, assessment and closing of Change control, Deviations, Out of Specification,
CAPA & Investigation reports.
• Participation in Internal Audits & Compliance Activity.
• Establishing & implementing quality system.
• Co-ordinate with the cross functional department whenever required.
• Facility round and document verification.
• Review QA documentation
• Preparation and Review of QA SOPs.
. QA SOPs compliance verification.
• Conduct risk assessment, investigations as per requirement
• Responsible for timely execution of self-inspection, vendor audits, revisions of
documents, regulatory audits

2. Research Associate (RA)

Role: 𝐒𝐫. 𝐑𝐞𝐬𝐞𝐚𝐫𝐜𝐡 𝐀𝐬𝐬𝐨𝐜𝐢𝐚𝐭𝐞 (𝐑𝐀)
Qualification & Experience: 𝐌.𝐒𝐜./𝐌.𝐏𝐡𝐚𝐫𝐦 𝐰𝐢𝐭𝐡 𝟓-𝟖 𝐲𝐞𝐚𝐫𝐬 𝐨𝐟 𝐫𝐞𝐥𝐞𝐯𝐚𝐧𝐭 𝐞𝐱𝐩𝐞𝐫𝐢𝐞𝐧𝐜𝐞

Job Description

• Compilation, review and preparation of eCTD/CTD documents for regulatory submission.
• Prepare COPP, FSC application for export registration.
• Prepare documentation of FDCA, CDSCO, ISO, GLP, NABL and USFDA and compliance
thereof.
• Prepare and submit applications for Medical devices to CDSCO.
• Responsible for Clinical trial approval and registration -IEC, CTRI and like.
• Responsible for monthly/quarterly return filing of RS-II/Controlled substances stock
maintained/consumed to statutory authorities.
• Preparation for various lab accreditation applications/proposals.
• Compile and prepare dossier of Herbal products.
• Handling query responses from regulatory authorities.
• Review of STPs and SOPs pertaining to RA
• Responsible to ensure all the regulatory issues are handled as per respective SOPS,
investigated to identify the root cause /most probable root causes.
• Prepare change control impacted in regulatory dossier/RA dept. SOPs.
• Responsible to review documents like change control, deviation etc. which impacted in
regulatory bodies.
• Coordinate with respective department for dossier preparation time to time.
• Participates in the quality Operations management training to achieve effective and
efficient operation and Organization goals.

3. Executive (IT)

Role: 𝐒𝐫. 𝐄𝐱𝐞𝐜𝐮𝐭𝐢𝐯𝐞 (𝐈𝐓)
Qualification & Experience: 𝐌.𝐒𝐜./ 𝐁𝐄 / 𝐌𝐂𝐀 (𝐈𝐓) 𝐰𝐢𝐭𝐡 𝟓-𝟖 𝐲𝐞𝐚𝐫𝐬 𝐨𝐟 𝐫𝐞𝐥𝐞𝐯𝐚𝐧𝐭 𝐈𝐓 𝐞𝐱𝐩𝐞𝐫𝐢𝐞𝐧𝐜𝐞 (𝐏𝐫𝐞𝐟𝐞𝐫𝐚𝐛𝐥𝐲 𝐨𝐟 𝐏𝐡𝐚𝐫𝐦𝐚 𝐈𝐧𝐝𝐮𝐬𝐭𝐫𝐲)

Job Description

• Should aware of ISMS policies and guidelines, Systems Management, IT
infrastructure, installing & configuring servers, IT inventory, Host & manage websites,
IT deployment, IT Budgeting, Managing Web servers
• Network Management and security Management
• Install and configure Antivirus software and Monitoring Tools.
• Troubleshoot and resolve Network, Server, PC, and Printer issues.
• Assembling PCs and troubleshooting of Hardware issues
• Installation and configuration and troubleshooting of network printers.
• Trouble shooting connectivity issues – LAN, WAN
• Managing user accounts, permissions, user rights, account policies, security policies
and performed software and hardware maintenance, administering using Group policy,
maintaining windows servers.
• Installation of latest patches and hot fixes on the operating system.
• Configuration and troubleshooting of mail server related issues.
• Installing windows operating systems, software, Sharing files and printers within the
network
• Maintain Server Room, maintain relationship with Vendors. Maintain all office
Computers & Laptops & maintain IT related documents & records.
. Look out CCTV Camera & Access Controls.
. Good knowledge of end-to-end IT infrastructure processes.