At Brooks Steriscience Limited, we are committed to excellence in pharmaceutical manufacturing and quality assurance. Located in the vibrant region of Vadodara, Gujarat, our state-of-the-art facility specializes in API and Sterile API production, adhering to the highest standards of GMP and FDA regulations.
Brooks Steriscience Limited
Block No 61/62, Village Manglej, Nareshwar Road, Tal Karjan, Dist: Vadodara, Gujarat
[caption id="attachment_77605" align="aligncenter" width="930"] Brooks Laboratories limited Recruitment - Job vacancies[/caption]
Position: Executive (Documentation) - Production Department
Qualification:- MSc/BSc (Familiarity with GMP, FDA regulations, and other relevant quality standards)
- 5 to 8 years in Pharma Industry (API Plant)
- Manage Drug product manufacturing and QMS compliance
- Prepare and revise Master Production/Formula Records (MFR/MPR), Batch Manufacturing/Production Records (BMR/BPR), SOPs, Trend, Qualification documents, Protocols, and Reports
- Manage the change control process for production documentation, ensuring changes are properly documented, approved, and communicated
- Effectively implement CAPA
- Proficiency in SAP system
- Prepare for and participate in internal and external audits and inspections related to production documentation and implement audit CAPAs
- Experience in USFDA approved site
Position: Executive (Sterile API) - Production Department
Qualification:- B.E. / B.Tech. / B. Pharma / MSc.
- 5 to 8 years in Pharma Industry (Sterile API)
- Lead and supervise production teams during assigned shifts, ensuring the effective operation of Sterile API manufacturing processes
- Ensure compliance with Sterile processing procedures, including aseptic techniques, cleanroom protocols, and environmental monitoring
- Implement and maintain practices that uphold the sterility of the production environment
- Enforce adherence to GMP and other relevant quality standards specific to Sterile API manufacturing
- Work closely with the Production Planning team to ensure accurate scheduling and sequencing of Sterile API production activities
- Proficiency in handling critical equipment (Reactors, Filters, ANFD, Powder Filling, Autoclave) and working in a batch process, cGMP environment
- Experience in USFDA approved site and SAP system
Position: Officer - Production Department
Qualification:- MSc/BSc
- 2 to 5 years in Pharma Industry (API Plant)
- Execute API manufacturing processes under the guidance of senior production staff
- Follow GMP and SOPs to maintain high-quality production
- Accurately document production activities, including batch records, logbooks, and other required paperwork
- Adhere to safety protocols and guidelines to ensure a secure working environment
- Report safety concerns or incidents promptly to the supervisor
- Identify and report deviations, abnormalities, or issues during production processes
- Monitor environmental conditions within the production area to meet specified requirements
- Proficiency in handling critical equipment (Reactors, Centrifuges, Dryers, FBD, Filters, ANFD, Hydrogenator) and working in a batch process, cGMP environment
Position: Officer/Operator (Sterile API) - Production Department
Qualification:- MSc/BSc
- 5 to 8 years in Pharma Industry (Sterile API)
- Execute Sterile API manufacturing processes according to SOPs and aseptic processing guidelines
- Operate and monitor equipment and machinery involved in Sterile processing
- Adhere to Sterile processing protocols, including gowning procedures, cleanroom behavior, and environmental monitoring
- Maintain awareness of aseptic techniques and contribute to the maintenance of sterility
- Follow GMP and quality standards specific to Sterile API manufacturing
- Proficiency in handling critical equipment (Reactors, Filters, ANFD, Powder Filling, Autoclave) and working in a batch process, cGMP environment
- Contribute to environmental monitoring activities to meet Sterile processing specifications
- Work in shifts and report to the Shift Incharge
Position: Executive (Shift In Charge) - Production Department
Qualification:- B.E. / B.Tech. / MSc/BSc
- 5 to 8 years in Pharma Industry (API Plant)
- Supervise and lead production teams during assigned shifts, ensuring smooth and efficient operation of API manufacturing processes
- Collaborate with other shift incharges and production managers to facilitate seamless transition between shifts
- Proficiency in SAP system
- Proficiency in handling critical equipment (Reactors, Centrifuges, Dryers, FBD, Filters, ANFD, Hydrogenator) and working in a batch process, cGMP environment
- Provide training and mentorship to production staff on API manufacturing processes, safety protocols, and regulatory compliance
- In-depth knowledge of GMP, safety regulations, and quality standards in API production
- Knowledge and compliance of clean room equipment and area
- Experience in USFDA approved site
For all positions, please ensure your CV includes relevant experience and clearly outlines your qualifications and responsibilities in previous roles. We look forward to welcoming dedicated and skilled professionals to our team.