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QA, QC, Regulatory Affairs Jobs in HLL Lifecare

By: Pharma Jobs | Views: 2648 | Date: 23-Dec-2014

HLL Lifecare Limited, a Mini Ratna Central Public Sector Enterprise under the Ministry of Health & Family Welfare, Govt. of India is a global provider of high quality healthcare products & services. With state-of-the-art manufacturing facilities spanning across India, HLL is diversifying into vaccine manufacturing, lifecare services, sanitary napkins besides engaging in procurement consultancy, healthcare infrastructure development and facility management.


Career in QA, QC, Regulatory Affairs in Vaccine department at HLL Lifecare| M.Pharm, M.Sc

HLL Lifecare Limited, a Mini Ratna Central Public Sector Enterprise under the Ministry of Health & Family Welfare, Govt. of India is a global provider of high quality healthcare products & services. With state-of-the-art manufacturing facilities spanning across India, HLL is diversifying into vaccine manufacturing, lifecare services, sanitary napkins besides engaging in procurement consultancy, healthcare infrastructure development and facility management.

Post: Assistant Manager- QA, Deputy Manager-QC, Deputy General Manager - RA, Junior Officer - Viral vaccine

  • Assistant Manager - QA {see below}
  • Deputy Manager - QC
  • Deputy General Manager - RA
  • Junior Officer - viral vaccine

ASSISTANT MANAGER (QA VALIDATION)

No.of post: 1

Tasks
- To execute and support quality assurance activities related to commissioning, qualification and validation of facilities and equipment of biological manufacturing & testing facilities.
- Should be conversant in study protocol preparation related to Process validation/ verification, cleaning process validation/ verification, equipment (e.g. autoclave, vial washing m/c, tunnel, lyophilizer, filling m/c, sealing m/c, CIP & SIP unit/s, cold room/s etc..), facility, and utility (e.g. Water & HVAC) qualification/ caliberation, Microbiological/ analytical method validation, Miscellaneous validations like media fill, hold time studies, GxP etc.., requalification at site
- Good understanding of Engineering fundamentals and instrumentation.
- Preparation of Documents (SOPs, Validation/ calibration documents) with good documentation skills.

Requirements
Maximum Age: 35 Years as on 01/12/2014.

Scale of Pay: AM: 12600-32500

Pay: Annual CTC AM: 5.50 Lakhs (approx.) at the minimum of the scale.

Qualification:
Essential:
Masters Degree in Pharmacy with atleast 60% Marks. Or Masters Degree in Science (Biochemistry /  Microbiology/ Biotechnology / Molecular Biology) or B. tech (Biotechnology) with at least 60% Marks.

Desirable: Phd

Post Qualification Experience:
Essential: Minimum 1 year  of Experience in Pharmaceutical / biotechnology area in the field of vaccines (bacterial/viral) in lower middle level position.
Should have good communication and interpersonal skills.

Additional Information:
Experience: Minimum 1 year
Qualification:
 M.Pharm, M.Sc
Reference Code: HBL/HR/041/2014
Contract Type: Executive - Permanent
Department: QA
Last Date: 24/12/2014

DEPUTY MANAGER(QC - RM & PM)

No.of post: 1

Tasks
• Manages the RM & PM testing operation, ensuring laboratory processes and provide high quality analytical support for manufacturing, while ensuring compliance of protocols, GMP’s, and safety regulations.
• Ensure the raw materials and packing materials testing (Primary and secondary),Printed packing material (Labels, Cartons and Leaflets etc.).
• Should have extensive experience in vendor qualification and outsource testing
• To lay down specification as per regulatory standards and should have experience in method validations.
• To finalize all equipment specifications and requirements related to RM/PM support for new facilities
• Effective in interdepartmental coordination like warehouse etc.
• Responsible for the compliance of the related regulatory requirements.
• Should have working, calibration& troubleshooting knowledge of all the equipment used in RM & PM Testing.
• To maintain records of all reference standards, retention samples etc..
• Attend the customer, regulatory and internal audits. With the consensus with QA and superiors incorporate the suggestions, changes if any are suggested during such audits.
• Ensure to follow in the department the GMP, Safety and other guidelines applicable.
• To oversee laboratory investigations and reports in response deviations and change control
• Work with direct reports to develop performance objectives and personal development plans and to monitor performance against the objectives.
• Provides leadership, management, and training.
• Review raw data, SOPs, protocols, policies and reports.
• Manage / support special projects as assigned.

Requirements
Requirements
Maximum Age:  35 Years as on 01/12/2014.
Scale of Pay: Deputy Manager (16400-40500)

Pay: Annual CTC - Manager: 6.55 Lakhs  (approx.) at the minimum of the scale.

Qualification:
Essential: Master’s Degree in Science (Chemistry/Biochemistry/ Microbiology/Biotechnology) with at least 60% Marks.

Post Qualification Experience:
Essential:
• Minimum 3years of experience in the field of RM/PM testing with pharmaceutical/ biotech sector and should be in the field of vaccines (bacterial / viral).
• 3 yrs in RM/PM testing and management of team members
• Wide experience in various RM/PM testing aspects in tune to regulatory requirements.
• Experience in preparation of URS, IQ and OQof analytical equipment’s and analytical method validation.

Desirable:
Experience in establishing RM/PM laboratory requirement’s, routine support for manufacturing release and handled new projects

Functional Area: QUALITY CONTROL

Additional Information:
Experience: Minimum 3 year
Qualification:
 M.Sc
Reference Code: HBL/HR/021/2014
Contract Type: Executive - Permanent
Department: QC
Last Date: 24/12/2014

DEPUTY GENERAL MANAGER (RA)

No.of post: 1

Tasks
Dealing with DCGI, WHO, FDA and other regulatory authorities.
Handling regulatory authorities in the regulatory audits, pre-clinical and clinical requirements of vaccine products.

Requirements
Maximum Age:  45 Years as on 01/12/2014.
Scale of Pay: DGM- 29100-54500

Pay: Annual CTC - DGM 11.50 Lakhs  (approx.) at the minimum of the scale.

Qualification:
Essential: Master’s Degree in Science (Microbiology/Biotechnology/ Biochemistry / Molecular Biology/ Pharmacy) or B.Tech in Biotechnology

Post Qualification Experience:
Essential:
Minimum 10 years of experience in handling Regulatory Affairs function of larger corporation out of which minimum 5 years should be in Middle level managerial position.
Experience in handling regulatory affairs matters of vaccines like Measles, Japanese Encephalitis, Pentavalent, Hepatitis B, Haemophius Influenza type B and Rabies.
The candidate should be a dynamic leader with excellent managerial skills with Excellent Communication Skills & Pleasing personality.

Functional Area: Regulatory Affairs

Additional Information:
Experience: Minimum 5 year
Reference Code: HBL/HR/014/2014
Contract Type: Executive - Permanent
Department: Regulatory Affairs
Last Date: 24/12/2014

Junior Officer (Viral Vaccine)

No.of post: 1

Tasks
• Media, reagent and glassware preparation for cell culture.
• Sterile ultra-filtration
• Environmental monitoring and validation of laboratory equipment.

Requirements
Maximum Age: 40 Years as on 01/12/2014.

Scale of Pay: Junior Officer (Viral Vaccine) (10085-24690)

Pay: Annual CTC - Junior Officer (Viral Vaccine) : 2.50 Lakhs (approx.) at the minimum of the scale.

Qualification:
Essential: Post Graduation degree in life science
Desirable: M.Sc(Microbiology)

Post Qualification Experience:
Essential:
Minimum 3 years of Experience in R&D

Desirable: Experience in biologicals

Functional Area: R&D (Viral Vaccine)

Additional Information:
Experience: Minimum 3 year
Qualification:
 M.Sc
Reference Code: HBL/HR/044/2014
Contract Type: Staff/Worker - Permanent
Department: R&D (Viral Vaccine)
Last Date: 24/12/2014

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