Work as Manager (QC Microbiology) in HLL Lifecare

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: Manager (QC Microbiology)

Tasks
• Manages the quality control microbiology laboratory operation, ensuring laboratory Processes provide high quality analytical support for manufacturing, maintenance, engineering and validation operations while ensuring compliance of protocols, GMP’s, and safety regulations.
• Should be broadly expertise in QC Microbiology and new projects/ GMP facilities commissioning and validation.
• Provides broad-based QC Microbiology expertise and counsel to and on behalf of the organization. This includes but is not limited to experience with EMP, Water testing, disinfectant efficacy studies, bio-burden, validation of microbiological test methods, sterility testing, endotoxin testing, microbial limits testing, GPT, microbial identification techniques and knowledge of commonly occurring and problematic microorganisms, and aseptic techniques.
• To provide back-up support for the environmental monitoring (laydown EMP) and critical utilities programs/ validation, facility qualification, cleaning validation, sterility, GPT, water testing, BET and microbial identifications.
• To finalize all equipment specifications and requirements related to microbiology support for new facilities including validation equipment’s
• To oversee laboratory investigations and reports in response to OOS, OOT, alert / action limits, etc. Deviations and change control
• Identify, develop and validate microbiological assays for raw material, in-process and finished product testing per appropriate GMP, USP and ICH requirements or guidelines.
• Regularly interact with senior management & Higher executive on matters concerning several functional areas, divisions, and/or other departments.
• Supports and/or coordinates regulatory audits as required.
• Work with direct reports to develop performance objectives and personal development plans and to monitor performance against the objectives.
• Provides leadership, management, and training for QC microbiology staff.
• Review raw data, SOPs, protocols, policies and reports.
• Manage / support special projects as assigned.

Requirements
Maximum Age: 40 Years as on 01/12/2014.
Scale of Pay: Manager (20600-46500)

Pay: Annual CTC - Manager: 08.00 Lakhs (approx.) at the minimum of the scale.

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

Post Qualification Experience:
Essential:
• Minimum 5 years of experience in the field of microbiology with pharmaceutical/ biotech sector and should be in the field of vaccines (bacterial / viral).
• 5 yrs in microbiology testing and management of team members
• Wide experience in various microbiological 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 microbiological laboratory requirement’s and handled facility commissioning and validation.

Additional Information:
Experience: Mini. 5 year
Industry Type: Pharma/ Biotech/Clinical Research
Reference Code: HBL/HR/019/2014
Functional Area: QC
End Date: 24^th December, 2014