Issues in the Philippines (Unemployment and Underemployment).pptx
Job openings at sterile manufacturing palnt
1. Job Openings for Sterile Manufacturing Plant (Pharma)
@ Hyderabad
Interested candidates can forward their resumes to rk@idealconsultants.com or
call at 9849006750
2. Position Qualification Experience Other
Lead- Sterility
Assurance (female)
M.Sc- Microbiology 8 to 10 years Work experience of
sterile injectable
liquid formulation
DGM / GM -
Production
Any PG 15 to 25 years Work experience of
sterile injectable
liquid formulation
preferably with
insulin product.
IPQA Lead- Visual
Inspection and
Packing
M.Sc- Microbiology /
Chemistry/
Biotechnology
9-11 years Work experience of
sterile injectable
liquid formulation
AGM Warehouse (
Female)
MBA 12 to 17 years Work experience of
sterile injectable
liquid formulation
3. Lead- Sterility Assurance
Job Description:
• Coordinate with manufacturing department to develop strategy, standards and
requirements for risk management, microbial control, sterility assurance and sterilization
Work with QA team to understand, communicate and address sterility assurance risks
Prioritize sterility assurance related initiatives and develop proposals for sterility assurance
related facility improvements
Provide support for investigations, troubleshooting and CAPAs
Assess operational and laboratory risks and trends in plants
Work with manufacturing and QC department to improve environmental monitoring
performance and practices
Write and review standard operating procedures related to sterility assurance function
Review aseptic process simulation protocols and write summary reports
Provide quality inputs for facilities during design phase
Review of technology transfer documents for projects
Participate in periodical verification of quality system by way of internal audits and readiness
for regulatory inspections, customer audits/GQA
Candidate Profile:
• M.Sc- Microbiology with 8 to 10 years of experience
Essential Technical Competencies:
Working experience as a Sterility Assurance professional
Thorough knowledge of applicable procedures, specifications, standards and regulations
(USFDA, MHRA, EUGMP etc.)
4. DGM / GM – Production
Job Description:
• Ensures that goods and products are processed efficiently, with respect to quality, quantity, planning, cost, HSE
requirements and regulations. Manages the resources, the planning, ensures the coordination and the control
of a production department in a site or a production unit .
To contribute in the definition and execution of the site strategy and is in charge of implementing Operational
Excellence standards (e.g : lean program). He plays a critical role in fostering motivation and excellence in his
teams.
Central coordination of production activities and staff. Assurance that products are manufactured according to
current GMP standards along with SOPs and BMRs. Assurance that documentation is duly executed. Assurance
that machines and equipment are qualified and validated and the they remain in a qualified and validated
status, including maintenance. Assurance of knowledge and technology transfer. Recruitment and training of
staff within his area of responsibility. Responsible for creation and update of SOPs and BMRs. Assurance that all
operators are certified for each operation.
Knowledge in sterile liquid injectable formulation activities lines including dispensing, aseptic addition,
filtration ,integrity clean in place (CIP),sterilization in place(SIP), Autoclave & Part washer operation.
Should have experience of handling team and train the team for aseptic area behaviors.
Working as per safety guidelines, focus on quality production. Also understand and execute the technology
transfer of new solutions and modifications adhering to regulatory compliance requirements.
Candidate Profile:
• Work experience of sterile injectable liquid formulation preferably with insulin product.
Work experience of support in aseptic filling activities functions.
Work experience as per cGMP& good in documentation.
Should have compounding/formulation knowledge.
• Should be working in Sr. Management position. (AGM & above)
Experience in Visual Inspection activities.
Willing to relocate to Hyderabad
Experience: 15-25 years
• Age: 35 - 45 years
5. IPQA Lead- Visual Inspection& Packing
Job Description:
• To ensure that all activities involved in visual inspection, labelling and packing functions are
in compliance with cGMP and standard operating procedures
Review and approval of master formulae, master packing record, protocols, reports, SOPs
and RSTs
To ensure Visual Inspection operator qualification program
To ensure finished product packaging profile without mix-ups
To ensure qualification and calibration of visual inspection, labelling and packing equipment
Responsible for site readiness towards self and regulatory inspections
To ensure the facility for cGMP compliance
Support to RA submission
To ensure vendor qualifications with respect to packing departments
Candidate Profile:
• M.Sc- Microbiology / Chemistry/ Biotechnology with 9-11 years of experience
Essential Technical Competencies:
• Working experience as an IPQA Visual inspection, labelling & packing professional
Thorough knowledge of applicable procedures, specifications, standards and regulations
(USFDA, MHRA, EUGMP etc.)
Excellent knowledge on Automatic Visual Inspection, labelling and packing systems handling
6. AGM Warehouse ( Female)
Job Description:
• To handle end to end warehousing operations.
Responsible for total materials.
Customs and excise related activities with proper maintenance of records.
Co-ordination with Purchase Department in arranging required inputs (Lab chemicals to raw materials) for
production.
Co-ordinate with QC for releasing and re-test of materials.
Co-ordinate with Production for Production Planning and Schedules.
Dealing with supplier and regarding material requirements to meet production and delivery schedules.
Effective Communication to all the concerned.
Good in working SAP environment.
Total inventory planning.
Man power handling.
Inventory verification at regular intervals.
Preparing detailed MIS covering stocks, inventory, production, dispatches etc.
Proper space management.
Arranging for return/destruction of rejected/obsolete materials.
Maintenance of imports / Exports and strict adherence to procedures.
Handling Customer and Regulatory Audits.
Standard Operating Procedures of Stores relating to MHRA, USFDA& EU Acceptance
Handling Of Customer Complaints.
Candidate Profile:
• MBA with min 15y experience in industry
Fluent english
Strategic thinking,
Cooperate transversaly,