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9 Job openings at Shilpa Medicare
About Shilpa Medicare

Shilpa Medicare Limited (SML) started its operations as API manufacturer way back in 1987 at Raichur, Karnataka- India. The commercial production in the SML was started in November 1989. Today Shilpa Medicare Limited is a global brand in manufacturing and supplying of affordable API and Formulation globally in different regulated markets.

Operator / Sr. Operator / Officer / Sr. Officer / Executive / Sr. Exec

Jadcherla

2 - 7 years

INR 2.25 - 6.0 Lacs P.A.

Work from Office

Full Time

We are having opeings in the below departments and should be expertise in the area. Department - Experience - No of openings - Positions OSD Manufacturing - 2 to 9 Yrs - 40 No's - Operator / Sr. Operator / Officer / Sr. Officer / Executive / Sr. Executive OSD & Inj Packing - 2 to 9 Yrs - 40 No's - Operator / Sr. Operator / Officer / Sr. Officer / Executive / Sr. Executive Warehouse - 2 to 9 Yrs - 45 No's - Operator / Sr. Operator / Officer / Sr. Officer / Executive / Sr. Executive IPQA Inj & OSD - 2 to 9 Yrs - 30 Nos - Officer / Sr. Officer / Executive / Sr. Executive Engineering - 2 to 7 Yrs - 45 No's - Technician / Sr. Technician / Officer / Sr. Officer / Executive

Senior Executive/ Assistant Manager - Purchase (Formulation)

Hyderabad

4 - 8 years

INR 4.0 - 8.0 Lacs P.A.

Work from Office

Full Time

Role & responsibilities • All Types of Consumables for SEZ Unit Chemicals, consumables • Inter Unit Transfers • QC Chemicals, Production Consumables Micro Biology Consumables, EHS & Eng maintenance • Send Enquiry for all vendors for Chemicals /Consumables materials • RFQ Comparisons for Consumables, Raw water, oil, & Gases • Materials delivery follow up as per PPIC-plant requirement • PO Creation for Chemicals / Consumables. PO Approvals Follow up with Approver. Approved PO's send to concern Vendors • New Vendor Code Creation & MPN Code creation • MPN Follow-up with DQA & PDD • Documents follow-up with vendors for VQ & PQ process. • Advance payment Request (DP), Advance & Overdue payments follow-up with Accounts Team. Preferred candidate profile * Preferred from Formulation Background * M.sc Freshers Also Eligible to Apply. Perks and benefits

Dy Manager/Manager- Regulatory Affairs- ROW - Formulations

Hyderabad/Secunderabad

5 - 10 years

INR 7.0 - 14.0 Lacs P.A.

Work from Office

Full Time

Roles and Responsibilities Should Have Formulation Experience. 1. Responsible for product registration in ROW (AFRICA, ANZ, ASIA, LATAM, CIS &, MENA). 2. Responsible and involving in the regulatory audits and coordinating with the auditors/customers. 3. Preparation, compilation and review of dossiers for RoW region in CTD /country specific format. 4. Co-ordinating with cross functional departments like API, R&D, QC, QA, PDD, Micro for documents required for dossier compilation for initial submission, query responses or other submission like tender activities. 5. Communicating with agents/partners for submission of Dossiers and further updates or requirements if any on product registration. 6. Responding to queries with in the time lines received from client/agency. 7. Preparation of check list as per country specific requirements in RoW region. 8. Review of documents like specifications/ MFC/ BMR/ PV/ Stability/ PDR/ DMF/ CoAs/Artworks and other quality related documents for their suitability for registration in RoW region. 9. Co-ordinating for CoPP, GMP, License and other required documents/certificates legalization activity required for dossier compilation and registration. 10. Maintenance of the dossiers, renewal files and variation approvals along with supporting documents in regulatory data base. 11. Identifying gaps in approved dossier, compiled and submit the post approval changes (Minor variations) to agent/agency. 12. Compilation and circulation of product approval package up on receipt of product approval/Minor variation approvals to concern departments. Desired Candidate Profile Should Have Regulatory Affairs Relevant Experience Perks and Benefits

Preclinical scientist

Hyderabad

6 - 10 years

INR 6.0 - 13.0 Lacs P.A.

Work from Office

Full Time

Role & responsibilities Support Preclinical Development Strategy Assist in devising and implementing preclinical development strategies for new drugs or generics, including literature review and assimilation of relevant scientific data. Contribute to the design and planning of in vivo and in vitro studies, ensuring alignment with regulatory and therapeutic goals. Study Management and Oversight: Coordinate and support the execution of pharmacodynamics, pharmacokinetics, and toxicological studies, often at contract research organizations (CROs). Verify test article characterization data and review preclinical study protocols, data, and reports for accuracy and compliance. Ensure timely execution of studies in collaboration with CROs and internal teams, maintaining data integrity and regulatory compliance. Data Analysis and Interpretation Compile, analyze, and interpret preclinical data, including statistical analysis of biological results. Prepare study findings for internal discussions, decision-making, and regulatory submissions. Present results in team meetings and contribute to technical reports, study summaries, and presentations. Regulatory Support Review and prepare documentation for regulatory submissions (e.g., IND, NDA, BLA), ensuring all preclinical data meet regulatory requirements. Address and resolve regulatory queries related to pharmacokinetics, efficacy, or toxicity by providing scientific justifications and literature support. CRO and Vendor Management Participate in the identification, selection, and management of CROs for preclinical studies. Set up contracts, handle shipments, and oversee administrative tasks related to external service providers. Cross-functional Collaboration Collaborate with internal and external stakeholders, including discovery research, clinical pharmacology, and regulatory affairs, to ensure seamless project progression. Contribute to the overall translational research strategy and integrate preclinical insights into broader project decisions. Documentation and Compliance Ensure that all work is conducted in a safe, ethical, and compliant manner, adhering to Good Laboratory Practice (GLP) and other relevant standards Preferred candidate profile Perks and benefits

Regulatory Affairs - US/EU/CA -Executive/Sr Executive

Hyderabad

2 - 7 years

INR 2.75 - 7.0 Lacs P.A.

Work from Office

Full Time

Role & responsibilities Handling of pre and post approval regulatory activities of US/EU/CA submissions. Review of developmental documents for regulatory submission. Good knowledge of handling CMC documentation for Dossier submission Compilation and Submission of Annual reports and Supplements. Having the experience of solid orals and injectables. Preparation of Sterility Assurance Package for injectable Dossiers. Preparation of Pre-IND/scientific advice meeting packages Drafting, compiling & eCTD publishing of dossiers for regulatory filings. Review of specifications and test procedure as per pharmacopoeia requirements. Providing regulatory support for customer filings and customer queries. Evaluation of regulatory authority deficiencies and preparation of action plan accordingly. Also follow up of response documents with concern stake holders. Evaluation and approval of QMS documents, wherever applicable. To update cross functional teams for different regulatory compliance & requirements. Responsible for outlining requirements for labelling, storage and packaging. Review of product development report and QBD concepts. Updating product approval package to plant team. Preferred candidate profile Should Have Formulation Regulatory Affairs Relevant Experience in US/EU/Canada Perks and benefits

Project Management Manager

Hyderabad

7 - 12 years

INR 7.0 - 10.0 Lacs P.A.

Work from Office

Full Time

Role & responsibilities Responsible for handling of CMO projects of solid orals and injectable products from project initiation to commercial launches Responsible for handling of site transfer projects that and will be SPOC for all projects that will be executed at CMO Responsible for preparation of project tracker and monitoring of project timelines as per set milestones Responsible for handling of activities related to new product launches from CMO sites for US/EU & Canada territories Should be able to coordinate with QP labs for method transfer activities and commercial releases Should be able to coordinate between customers, internal cross functional teams and CMO partners for project activities. Responsible for handling of customer communications of commercial projects Can share your profile to karthik.kumar@vbshilpa.com Preferred candidate profile Need profiles from Pharma Industry Perks and benefits

Walk In For IPM - Executive/ Sr Executive - Formulations

Hyderabad, Nacharam

2 - 5 years

INR 2.0 - 6.0 Lacs P.A.

Work from Office

Full Time

Job Description : M.pharm(Pharmaceutics) Patent Search and Patent Report preparation FTO analysis and timely updates of patent reports Additional experience in portfolio selection (new product identification) Hands on experience with patent databases like Scifinder, general search databases like WIPO, USPTO, Espacenet Qualification : - M.pharm(Pharmaceutics)

Walk-ins For Regulatory Affairs- ROW - Formulations

Hyderabad/Secunderabad

4 - 9 years

INR 5.0 - 12.0 Lacs P.A.

Work from Office

Full Time

Roles and Responsibilities Should Have Formulation Experience. Having vacancies in RoW (ASIA , MENA, LATAM, AFRICA) Regions Responsible for product registration RoW (ASIA , MENA, LATAM, AFRICA) Regions region Preparation, compilation and review of dossiers for region in eCTD/CTD/country specific format. Co-ordinating with cross functional departments like API, R&D, QC, QA, PDD, Micro for documents required for dossier compilation for initial submission, query responses or other submission like tender activities. Communicating with agents/partners for submission of Dossiers and further updates or requirements if any on product registration. Responding to queries with in the time lines received from client/agency. Preparation of check list as per country specific requirements region. Review of documents like specifications/ MFC/ BMR/ PV/ Stability/ PDR/ DMF/ CoAs/Artworks and other quality related documents for their suitability for registration in MENA region. Co-ordinating for CoPP, GMP, License and other required documents/certificates legalization activity required for dossier compilation and registration. Archiving/Maintenance of the dossiers, renewal files and variation approvals along with supporting documents in regulatory data base. Identifying gaps in approved dossier, compiled and submit the post approval changes (Minor variations) to agent/agency. Filing of variations if any and registration renewals. Compilation and circulation of product approval package up on receipt of product approval/Minor variation approvals to concern departments. Maintaining the product status (Registered and Under registration) in excel sheet. Desired Candidate Profile Should Have Regulatory Affairs Relevant Formulation Experience Perks and Benefits

Walk-ins For Quality Control (QC) - Formulations

Hyderabad/ Secunderabad

1 - 5 years

INR 2.5 - 5.0 Lacs P.A.

Work from Office

Full Time

Role & responsibilities Required for Quality Control(Formulations) Quality Control(QC)- Need 1 to 5 years of experience. *Analysis of Finished Product & Stability *GLP and LIMS, Documentation Preferred candidate profile Perks and benefits

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Shilpa Medicare

Shilpa Medicare logo

Shilpa Medicare

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Pharmaceutical Manufacturing

RAICHUR Karnataka

1001-5000 Employees

9 Jobs

cta

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