Home Production QA Manager | Titan Laboratories | Raigad, Maharashtra

QA Manager | Titan Laboratories | Raigad, Maharashtra

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Titan Laboratories Pvt.Ltd. is one of select few companies in India with a dedicated state of art WHO GMP facility for producing high quality Sustained and Modified Release Pellets, DC Granules& Taste Masked Granules. The plant is located in the green belt of Mahad industrial zone about 180Kms from Mumbai. It is strategically located on well connected Mumbai-Goa Highway.

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Titan is a specialty Pharmaceutical company engaged in developing and manufacturing Sustained and Modified Release Pellets using Innovative Drug Delivery Technologies Utilizing some of the best and latest processing machinery like Fluid Bed Processor with inherent built-in rotary unit coupled with Top And Bottom Spray arrangement. This is essential to achieve uniformity and efficiency in the layering and/ coating process which in turn will ensure inconsistent release characteristics. The facility of Extruder & spheronizer is also available for effective pelletizing selectivity depending upon dose requirements of actives.

At Titan Laboratories, we are firmly committed to Equal Employment Opportunity, a prerequisite to building a high-performance, global workforce making a difference. We are committed to creating one company, one team contributing to mission success. This can be achieved by capitalizing on diversity in our workforce and communities.

Position: Manager Quality Assurance

Location: Mahad, Raigad, Maharashtra, India

Job Description:

  • Finished Formulations Background with good Leadership Quality
  • Managing team persons direct reporters.
  • Spearheading the entire functions of quality management and regulatory approvals, a regulatory query related to dossiers support, CAPA preparation and compliance of regulatory audits and employee training on cGMP & guidelines
  • Supervising the activities like training need identification, arranging external training, selection of trainer and maintaining the schedules as per training plans
  • Maintaining the GMP level as per regulatory requirement every time and ensuring submission of executed batch documents of exhibit & validation batches to the RA

  • Liaising with the regulatory department for quarries or document related requirements
  • Monitoring the effective implementation of best manufacturing practice & QMS
  • Reviewing SOPs, SMF, VMP, Quality manual, HVAC manual
  • Conducting departmental training & internal audits
  • Verifying annual product review report
  • Planning stability study & preparing protocols as per ICH guideline Developing protocols and reports for validations and qualification
  • Led the training program (GMP & On Job Training), self-inspection, BMR/BPR preparation, APQR, equipment qualification, heating ventilation, and air conditioning system validation, water system validation & facility qualification
  • Managed the entire functions of quality management & regulatory approvals, training related to cGMP, incident investigation, change controls, deviations including non-conformities
  • Trained employees on basic cGMP, risk assessment and quality systems
  • Reviewed and approved process validation protocols, reports & functional SOPs

Note: Only Pharma Candidate from Finished Formulation ( Tablet & Capsule), Preferable Male Candidates

Qualification: B.Pharma & Above

Experience: 12-17 Years

Salary: Negotiable

Contact Details:

Ms. Shivali Khanna

shivali.k@titanpharma.com

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