Sr. Officer - Quality Assurance with Globally CDMO Partner For Derma

Greetings! & very warm welcome to BEST-FIT Recruitment Riders,

highly specialized Recruitment & Executive Search Partner for Pharmaceutical, Biotech, CRO, Chemicals, Medical Devices & Turnkey Pharma Projects Engineering-Construction Design Sectors.

professional career opportunity

Please see the following position summary:

• Client Name: Globally Preferred CDMO Partner for Derma

• Position: Officer / Sr. Officer - R&D Quality Assurance

• Markets: Global including Markets: USA, Canada & ROW

• Products: Topical Formulations & Ophthalmic Preparations

• Department: R&D - Quality Assurance

• Location: Mumbai

Job Profile:

• To ensure maintaining of Quality systems all across R&D.
• To review and approve quality management documents including change controls, Incident, SMF, deviations, investigation reports, CAPA, SOPs, URS, etc.
• To ensure Good Documentation Practices, Good Laboratory Practices & Data Integrity are followed by taking regular lab rounds and by taking periodic refreshment trainings.
• To review protocols and reports of analytical method validation, verification and method transfer activities of all departments.
• To review documents and monitor IVRT studies including development, validation and comparison studies.
• To review and approve qualification documents (IQ, OQ, PQ) and monitor the qualification, re-qualification and validation of instruments/equipments at R&D.
• To review specification and STP of Raw materials, Packing Materials and drug products.
• To review calibration and preventive maintenance schedule and summary of all R&D instrument/equipment.
• To ensure the preparation, issuance, revision, archival, distribution and retrieval of the documents like Formats, Log books, Protocols etc.
• To ensure document control on issued documents and master documents.
• To conduct Quality meet all across team leads and Quality review meeting with higher management as per decided schedule.
• To arrange & conduct Quality review meeting with management on quarterly basis.
• To conduct periodic audit trail of data generated by different software and also ensure appropriate data back-up procedure for data generated by using respective software.
• To conduct internal quality audits of cross functional departments.
• To face audits by external agencies, Self-Inspection by plant, by customers and provide compliances on observations within stipulated timelines.
• Ensure availability of complete log book & register of Quality Department to have all time audit readiness.
• To ensure availability of daily planning status, weekly planning & status on timely basis including sharing the status of QMS tasks, training schedule and calibration /maintenance schedule of all instruments and equipment's.
• Control on sample management system including handling of RLD, IP and any other test samples for method validation and IVRT studies.
• To support in reviewing response product related regulatory queries received from various regulatory agencies.
• Preparation, review and training of departmental SOPs as per current guidelines.
• To provide training to new employees for quality systems including quality SOPs and to monitor over all training process. Wherever applicable training/retraining to be imparted to cross functional team members.
• To monitor activities & work output of subordinator & ensure quality training on time to time basis to be imparted to new joiner as well as to subordinate.
• Wherever applicable, as and when required, advise shall be taken from consultant while working on daily tasks.

Desired Profile:

• M.Sc / M.Pharm with 4 to 5 years of experience in R&D QA within a pharma formulation company.
• Candidates preferred from pharmaceutical industry, Specifically from R&D Set-up.
• Excellent documentation and analytical review skills.
• Strong understanding of formulation and analytical development processes.
• Proficient in technical documentation review and QA systems.
• Ensure cGMP and GLP compliance during all R&D activities related to topical dosage formulations.
• Ensure Good Documentation Practices, Good Laboratory Practices & Data Integrity.
• Exposure in review of protocols & reports of analytical method validation, verification & method transfer activities.
• Familiarity with TrackWise / LIMS / Document Management Systems is an advantage.
• Exposure in Topical dosage form would be added advantage.
• Familiarity with ICH, cGMP, GLP, and regulatory guidelines.
• Good coordination, communication, & problem-solving abilities.
• Good problem-solving, analytical thinking, and team collaboration skills.

Recruiter's Contact Details:

BEST-FIT Recruitment Riders

G-7, Amrit Complex, R.V. Desai Road,

Near Goyagate Circle, Vadodara-390001, Gujarat

Mobile: 09722042906

E-Mail: post@bfrr.in

Website: www.bestfitrecruitment.co.in