- Date Posted25/08/2022
- Location (State / UT)
- Expiration date--
- Experience15 Years
- Desired QualificationBachelor Degree, Master’s Degree
- Salary in (₹)Negotiable
Responsible for leading Quality Operations and related aspects for the site with the following key responsibilities
- Quality oversight for Manufacturing and Packaging QA, Incoming Quality, Engineering QA, QC
- Laboratories, Investigations QA, and Validation operations QA.
- Implementation of global quality policies, and procedures and ensuring their compliance
- Monitor quality indicators for operations and ensure controls are in place & maintained for cGM activities.
- Monitor Manufacturing and Packing activities to ensure compliance with the systems and procedures as per cGMP. e Responsible for trending of quality indicators in manufacturing operations.
- Provides technical, quality oversight and support to the SQOL in making quality decisions on corporate hold, High-Risk Deviations from the manufacturing/packaging areas quality-driven metrics.
- Ensures all investigations are appropriately investigated prior to batch release A system for batch release is developed and executed as a part of routine commercial operations. Mentor the team in current expectations of production and process controls to make quality decisions
- upstream of the process to mitigate downstream risk.
- Partnership with operations team for driving best practices.
Role & Responsibilities:
Complexity and Scope of Responsibility
Sets objectives for and manages multiple projects/ ongoing work activities of moderate complexity within Sub Business Unit/Sub Operating Unit
- Manages and leads people, technological and financial resources at the Sub Business
- May lead by influence rather than direct authority
Breadth and Depth of Knowledge
- Provides technical/functional leadership to teams
- Leverages technical/functional expertise across own and related disciplines.
- Demonstrates comprehensive industry knowledge.
- Exhibits business expertise and an understanding of the external marketplace and customer requirements.
- Actively shares knowledge with others across multiple Sub Business units/Sub Operating units through existing knowledge-sharing processes/systems
- Encourages others to share knowledge across the organization.
Innovation and Risk-Taking
- Identifies existing process/product improvements
- Develops innovative, advanced new concepts that improve processes/products across own and related disciplines
- Takes appropriate risks to achieve desired results
The complexity of Decisions (e.g., Ambiguity, Complexity of Solutions)
- Solves complex problems, where previous experience outside of own area may be relevant.
Impact of Decisions
- Decisions impact multiple Sub Business Unit/Sub Operating Units’ mid-term objectives
- Significant or long-term decisions are reviewed by senior management
Vision, Strategy, and Business Alignment
Establishes operational activities/projects that support mid-term goals and set the direction for the Sub Business Unit/Sub Operating Unit.
- Recognizes development needs and identifies/creates development opportunities (e.g., special assignments) for colleagues within own Sub Business Unit/Sub Operating Unit
- Develops a talent base and anticipates development needs within the area of responsibility.
- Manages performance of direct and indirect reports and supports Sub Business Unit/Sub Operating Unit objectives through goal setting, ongoing assessment and coaching, and performance evaluation.
- Uses communication to help ensure alignment within and outside of Sub Business Unit/Sub Operating Unit
- Creates and delivers presentations to direct reports and other internal stakeholders across Sub Business Unit/Sub Operating Unit.
- Manages teams that execute direction for the Sub Business Unit/Sub Operating Unit
- Provides input to senior management decisions that may have an impact on business direction within the Sub Business Unit/Sub Operating Unit
- Partners with Global Business Unit/Global Operating Unit or Sub Business Unit/Sub Operating Unit leadership to accomplish objectives.
Prepares for and manages change that impacts the Sub Business Unit/Sub Operating Unit.
QUALIFICATIONS: Graduation or Post Graduation in Pharmacy or Science with 15+ years of experience in Quality Assurance or Quality Control, Preferably sterile dosage form facility.