Biological E. Limited, the first private sector biological products company in India and the first pharmaceuticals company in South India was established in 1953. BE is also the first pharmaceutical company in South India. Ever since its inception, the focus is on providing affordable access to quality healthcare. The branded formulation business has consistently remained as a strong pillar for the organization.
Biological E. Limited (BE) invites experienced, dynamic, and self-motivated candidates for the following positions at its Specialty Injectables Business (SGI), Shamirpet, Hyderabad.
Job Description: Biological E. Limited is hiring for IPQA, Pharma SGI-USFDA Approved plant, Shamirpet location, Hyderabad.
- Position: Executive
- Qualification: B.Pharmacy/M.Pharmacy/M.Sc
- Experience: 2 to 5 years
Job Description:
- Providing line clearances during the manufacturing activities like Dispensing, Manufacturing, Visual inspection, Packing and Dispatch activities.
- Collection and submission of in process samples, finished product samples, stability samples, control samples, cleaning samples and other samples as described in respective procedures/batch manufacturing records and packing records/protocol.
- Performing AQL inspection and periodic inspection of control samples.
- Review of the executed batch manufacturing records, batch packing records and protocols.
- Preparation and evaluation of the visual inspection defect set, test set and qualification of Visual inspectors.
How to Apply:
- Interested aspirants with relevant skills set can share their resumes to Mahesh.Patsamatla@biologicale.com
- Job Location: Shamirpet location, Hyderabad
Biological E. Limited is hiring for Regulatory Affairs, Pharma SGI-USFDA Approved plant, Shamirpet location, Hyderabad.
- Position: Executive/Sr. Executive
- Qualification: M.Pharmacy
- Experience: 4 to 9 years
Job Description:
- Review of all the relevant documents related to product development (development / tech-transfer) and submission batches.
- Co-ordinate with various cross functional teams for formulization of dossier and other applicable submissions as the case may be.
- To collate and compile dossier as per CTD requirement and any related submissions as per filing plan.
- Compilation of DMF as per regulatory requirements and submission to the Agencies.
- Formalization of dossier in NeeS/electronic format and validation of the same using e-validators.
- To understand and interpret various regulatory guidance documents.
- Handling and responding to all product specific queries arising from various customers and regulatory authorities.
- Review and submission of required product information and mock-ups to MOH during the procedure, per the country regulations.
- Ensure relevant SOP’s are understood and practiced on routine basis.
- To maintain and handle product life cycle management under direct supervision of supervisor/head.
- Change Control approval activity in compliance with regulatory requirements & maintenance of change control tracker.
Interested aspirants with relevant skills set can share their resumes to Mahesh.Patsamatla@biologicale.com
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