JOB DESCRIPTION:
Primary Job Function:
- Oversight of assigned TPM sites for Product, Site & Quality compliance.
- Lead and guide the team for TPM Operations and functionality on GMP aspects and Abbott policies and procedures, though site visits and ensure an audit readiness of sites.
- Ensure Quality Agreements in place with the TPMs & assess site performance through the Quality metrics on periodic basis.
- Ensure Pharmacopoeial compliance of Abbott products manufactured at sites.
- Ensure implementation of Abbott quality audit CAPA & closure at sites.
- Ensure timely investigation of the Market complaints within SLA, root cause analysis, CAPA implementation and effectiveness check.
- Coordinate with responsible CFT for NSQ's, Govt Agency responses.
- Review & assess change controls, deviations, OOS/Failures, stability data related to Abbott products.
- Monitor and support projects as assigned by the Manager.
- Tech Transfer at TPMs including Analytical method transfer, FLQR (First Lot Quality Review )
- Ensure and review GSR notifications and timely compliance at TPMs impacting Abbott products
- Ensure compliances related to regulatory changes impacting Abbott products and processes.
- Recruit, mentor, train and develop TPM QA India team members.
- Prepare Risk assessment for critical observations and concerns identified while TPM audits of with appropriate mitigation actions.
- To perform assessment of new site for cGMP compliance as and when required.
Stakeholder Management
- Set and manage of expectations with stakeholders (Commercial, Planning, TPMs, MS&T, Regulatory, Labelling w.r.t Quality and Regulatory compliance.
- Support AVD projects , Tech transfer projects, New product introductions as per Abbott process and policies.
Expectations & Skills :
- Leverage knowledge, people networks inside and outside the company, out of the box thinking to resolve problems impacting Quality and regulatory challenges etc. impacting Abbott business.
- Flexible, proactive and motivated by the opportunity to optimize structures and processes
- Work collaboratively with colleagues to achieve organizational goals
- Ability to adapt in a high pressured an ever-changing business environment
- Ability to constructively cope with conflicts
- Strong and proven analytical, organizational and decision-making skills
- Strategic thinking, result and compliance oriented
- Good interpersonal and communication skills
- Resolution driven with adequate technical expertise
- Ability to work efficiently in complex and deadline-driven operations, not losing focus on accuracy and quality
- Proven track record to set priorities and adapt them accordingly at short notice
- Effectively work on multiple, unrelated projects simultaneously
- Provide expert guidance to team and CFTs on quality aspects and requirements supporting business
- Ability to influence others. Intercultural competence.
- Ability to understand the impact of business development decisions and contractual language on the Operations organization.
- Ability to handle large volumes of confidential information and data and be able to determine how and when to inform upper management on quality related matters. Have a good control on Product database related to Quality.
Team Management
- Develop a high-performance team by continuous monitoring and provision of guidance to develop the team
- Identify improvement areas and conduct/drive initiatives for training sessions to upskill people to ensure functional knowledge of process.
Position Accountability/Scope:
- Key contact for Quality aspects for South Zone sites & products.
- Support and navigate to CFTs for Quality related matters for impacted products
- Quality Technical Agreements.
- Compliance to Abbott procedures and policies.
- Tech Transfer and FLQR
- Metrics review and management review.
- Change Control Management
- Implement Quality policies and EQDs.
- Ensure an efficient exchange of information and a close working relationship with the CFTs for regulatory and Pharmacopoeial changes impacting Abbott products
- Provide guidance to TPMs for the compliances and investigation support for quality failures like Market complaints investigations, OOS, OOT.
- Establish and maintain an expanded network of contacts to share best practices, expertise related to Quality and Regulatory changes.
- Promote quality and compliance, simplification and standardization in Divisional TPM QA
Leadership / Team leading:
- Lead cross-functional, key contacts for Quality Aspects to support business.
Minimum Education:
- B Pharm /M. Pharm / Master in Science
- Any additional education is an added asset.
Minimum Experience/Training Required:
- 20 years of experience in NPI, QC / QA, QMS, R&D QA, TPM Management, Tech Transfer, Dossier review, Due Diligence of products and sites.
- Required to have managed TPM's in a significant capacity.
- Knowledge of regulations of markets such as Latam, APAC, EU is required
Languages:
- Proficiency in English
- Other languages are advantageous
The base pay for this position is
N/A
In specific locations, the pay range may vary from the range posted.
JOB FAMILY:
Operations Quality
DIVISION:
EPD Established Pharma
LOCATION:
India Mumbai : BKC Building
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Not specified
MEDICAL SURVEILLANCE:
Not Applicable
SIGNIFICANT WORK ACTIVITIES:
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
