Job Description
This employment opportunity is offered by a client of Abhisree Systems Pvt Ltd for their pharmaceuticals manufacturing operations based in Bangalore. Details are given below:
Job Interactions & Interface:
Internally this position interacts with all departments within the organization and with management and employees. Externally this position interacts with governing authorities, industry organizations, consultants & vendors.
Job Requirements
- Provides leadership and direction to a team of 25+ Quality control professionals; grows and develops the team to meet evolving business needs; is accountable for Quality Control.
- Ensures that a robust cGMP training program is developed and administered
- Ensures that all products compounded at the site are produced, tested, and released in compliance with SOPs, cGMP- s, FDA, and DEA requirements.
- Improves, develops, establishes, and drives contemporary Quality Systems and processes
- Leads a Quality metrics program to enable a strong Management Review
- Collaborate and facilitates interactions between Quality, Pharmacy and Operations teams to meet customer requirements and timelines, while maintaining compliance.
- Ensures that systems, resources, and action plans are consistently reviewed and decisions made to enable sustainable compliance.
- Manages customer complaints, makes batch rejection decisions and manages recall decisions in conjunction with the quality operations head
- Establishes procedures and specifications affecting product quality and oversees the development of batch records, SOPs, and validation protocols
- Directs continuous improvement initiatives to accomplish compliance, productivity, cost-effectiveness and enhanced efficiencies of processes and procedures pertaining to Quality.
- Prompt communication to Site Head / Management any other management of critical cGMP and/or non-compliance issues.
- Acts as a member of the site leadership team and engages in business decision-making from a Quality perspective.
Additional
- Provides work direction plus has responsibility for hiring, promotions, transfers, performance management, discipline, and termination
- Identify resource and skill gaps and recruit staff as required and effectively outsource projects as needed
- Lead an experienced team of professionals and provides training on quality policies and procedures, and regulations and guidelines, both existing and emerging
- Execute other duties as may be required by the MD / Management Team and other members of Leadership Team as training and experience allow.
Qualification & Experience
- B.Sc./M.Sc., B.Pharm/M. Pharm, Ph.D. in chemistry, microbiology from a reputed college, with about 15+ years of experience in reputed API/Bulk drug manufacturing organization.
Interested candidates may forward their profiles in MS Word format to [Confidential Information]
Kind regards,
Employement Category:
Employement Type: Full time
Industry: Pharmaceutical
Functional Area: Quality Control
Role Category: Head
Role/Responsibilies: Head/VP - Quality Control [Pharmaceutical Co, Bangalore]
Contact Details:
Company: Abhisree Systems
Location(s): Bengaluru
Keyskills:
Gmp
QA/QC
QC/QA
Validation
AHU’s
AHU
Calibration
Safety
Law
Legal
plant safety
food laws
preventive maintenance
Sops
master formula records
Quality Control
(QC)