About The Position
The incumbent is accountable & responsible for Review of Batch documents & Batch release in accordance with GSK QMS & applicable regulatory requirements and acts as the first contact point for any Quality issues in area of operation. To improve the effectiveness of quality in preventing, identifying and addressing quality issues by encouraging proactive quality culture and continuous improvement. To maintain presence and be accountable for key quality decision-making or quality escalations. To provide first line support to Engineering & Utilities areas and maintain inspection-readiness through independent checks.
Requirements
- Minimum Level of Education - B. Pharm / B. Sc./ M. Pharma / M. Sc.
- Area of Specialization - Pharmacy / Chemistry
- Minimum Level of Job-Related Experience required - 7 to 10 years
- Capability to understand Regulatory, QMS & Site Batch release SOP requirement indetail.
Nice To Haves
- Preferred Level of Education - Masters
- Area of Specialization - Science/Pharmacy
- Knowledge of Regulatory & QMS Requirements
- Good knowledge of computer software (Word, Excel and Power Point)
- Good interpersonal, Excellent oral and written communication skills
- Ability to problem-solve and use own initiative.
Responsibilities
- Ensures compliance and inspection readiness.
- Ensures release of bulk and finished products, meeting the statutory and QMS requirements, to market.
- BMR & BPR review and subsequent compliance review, Analytical report review and CPP trending
- Handling of dMERP (SAP) system related to batch release and other QA transactions to enable batch release process is followed as per SOP.
- Ensures that the manufacturing & packing operations on shop floor are in compliance with regulatory and QMS requirements.
- Ensures support provided for timely compliance to all audit observations in the area.
- Reviews Master BMR / draft MFR of products manufactured and packed in area of operation as per regulatory requirements and SOPs.
- Supports internal QMS activity for Engineering, Warehouse, Administration, PR&D,EHS,HR,Validation,L&D and Planning.
- Supports implementation of Quality Improvement Plan for Quality department.
- Support closure of deviations and investigations.
- Supports/conduct Self Inspection audit as per schedule.
- Support for internal and regulatory inspections
- Maintain presence across area of responsibility and be the first line of contact to support initial management of quality issues and be accountable for key quality decision making across activities such as the initial impact assessment for deviations.
- Provide guidance during GMP activities to proactively detect potential quality issues through active observation in real-time, allowing for timely interventions to prevent deviations and defects at Engineering & Utility areas
- Ensure adherence to frequency of oversight mandated in the Quality oversight schedule at Engineering & Utility areas and production areas.
- Foster a Quality Starts With Me (QSWM) culture by providing coaching to employees on the importance of following procedures, doing the right thing and explaining the why and the impact non-compliance can have on product quality and patient safety at Engineering & Utility areas.
Benefits
- Clear career progression and regular opportunities to learn through coaching and cross-functional collaboration.
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
