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Manager-Management Audit

Location: Hyderabad / Secunderabad

CA

Years of experience 5-7 Yrs

Job Responsibilities

1) Accountable for Planning, Execution and monitoring Management Audit and assisting him in finalizing the Audit report for submission to the Audit committee and members of the Top Management team.

2) Supervision of all Audits for cost reduction and adherence to companies policies.

3) Timely completion of Projects.

4) Propose system improvement.

5) Risk based Audit

6) Able to lead a team.

Cost to company (range) Maximum upto 10Lakhs

Prefer from Manufacturing, Pharma, Cement

Contact

Ashwini / R Varadarajan

Polaris Management services pvt ltd

2B, Sri Krishna Kaushikam,

2-2-647/287/12, Srinivasanagar Colony,

Baghamberpet

HYDERABAD -  500013

Email: polarisindia@gmail.com

Telephone 09949751412

Posted under Accounts / Finance Jobs, Hyderabad Jobs, Jobs By Category, Jobs by Location, Secunderabad Jobs

Leading Pharmaceutical Company

Requires

Team Member -(Qualification Group)

M. Pharm, B.Tech (Chemical / Mechanical / Electrical), 3 – 5 years in Qualification activities

Job responsibilities:

Review and assist in preparation of User Requirement Specification, Design Qualification documents

Review, evaluate and approve Change Request Notes

Prepare & / or Assist in preparation of SOPs, Operating Instruction, Cleaning Procedures

Prepare and review validation master plan, cleaning validation master plan and computerized systemvalidation master plan.

Responsible for qualification Manufacturing Equipment, HVAC Units, Utilities which shall include

Preparation of Protocols

Preparation & review deficiency reports/deviation reports etc

Preparation of summary reports and compilation of qualification report

Execution of Qualification Protocol which shall include

Co-ordinate with vendor / Cross Functional Team for calibration activity

Co-ordinate with cross sectional team carryout all Installation, Operational and Performance Qualification Tests

Arrange test instruments, standard instruments, materials required for the qualification activity.

Ensure that qualification is carried out as per protocol and qualification protocol meets the cGMP and regulatory requirements.

Prepare and execute cleaning validation protocols

Prepare & execute Qualification protocols

Prepare & execute Computer System Validation protocols.

Follow-up and co-ordinate with cross functional team for execution of cleaning validation

Review of updated cleaning matrix, monitor cleaning validation program as per policy and procedure

Review and approval of Qualification documents, Plan for training to the operators and other personnel associated with operation, cleaning and maintenance of equipment

Give the input for the monthly reporting system. Participate in the internal and external audits, present the document to the auditors/inspection team

Prepare the response to the internal/ external audit observation coordinate with QA for CAPA for incidents, deviations, audits reports

Troubleshoot, assist in trouble shooting of equipment breakdowns, process related issues etc.

Key performance Indicators:

Should complete the allotted activities within the time

Activities to be completed on RFT (Right first time) basis as an objective.

Key personal attributes:

Should have good communication skills

Should have good technical writing skills

Should have good managerial skills

Willing to travel frequently to other manufacturing sites.

Operating Network:

The position will interact with different departments like,

Manufacturing

Quality control

Quality Assurance

Projects

Engineering

Supply chain

Location Hyderabad / Secunderabad

Contact

Madhavi /R Varadarajan

Polaris Management services pvt ltd

2B, Sri Krishna Kaushikam,

2-2-647/287/12, Srinivasanagar Colony,

Posted under Hyderabad Jobs, Jobs By Category, Jobs by Location, Pharmaceuticals, Secunderabad Jobs

Leading Pharma Company

Requires

Head Clinical Research /Operations

Master /Bachelor Degree in life sciences or allied medical fields (e.g., M-Pharm/MBBS/PhD)

Minimum of 8 – 12 years of clinical research/ operation experience.

Knowledge of GCP, ICH, GLP and GMP

• Proficient computer skills

• Good project management skills

Key Responsibilities

• Oversee and Manage Contract Research Organizations (CROs)

• Managing project teams for deliverables

• Interactions with various related departments (viz. Manufacturing, QA, RA)

• Overseeing the Investigational Product management and budgeting for clinical trials

• Manage clinical study monitors and interact with investigational sites.

• Track enrollment and subject progress.

• Review monitoring reports submitted by monitoring personnel.

• Facilitate and track the generation, transfer, and resolution of all queries leading up to locking clinical databases

• Manage the transfer of information and documents between Sponsor and Contract CRAs, and Sponsor and Investigational Sites.

• Author/review standard operating procedures / other system initiatives related to various functional areas.

• Participation in DCGI inspections as it related to sponsor pre-approval inspection and investigational site inspections.

Desired Skills/Competencies

• Demonstrated experience managing multiple projects simultaneously with aggressive timelines.

• Demonstrated experience with management of Phase 3 multicenter/multinational clinical studies, desirable in the biosimilar/ biologics / therapeutic oncology.

• Demonstrated experience managing CROs and/or clinical monitors simultaneously with given timelines.

• Experience and demonstrated ability to manage at a high level of productivity with minimum infrastructure.

• Experience in budget planning, management and reconciliation.

• Proficient knowledge of Excel, problem solving and analytical skills required.

• Ability to function well in a cohesive management team environment, with strong goal and results orientation.

• Proven verbal and written communication skills.

Location: Hyderabad / Secunderabad

Compensation: Rupees 14,00,000 – 20,00,000/-

Contact

Ashwini / R Varadarajan

Polaris Management services pvt ltd

2B, Sri Krishna Kaushikam,

2-2-647/287/12, Srinivasanagar Colony,

Baghamberpet

HYDERABAD -  500013

Email: polarisindia@gmail.com

Telephone 040-27403495

Posted under Hyderabad Jobs, Jobs By Category, Jobs by Location, Pharmaceuticals, Secunderabad Jobs

Leading Pharmaceutical Organization in India

Requires

Clinical Research Director or Sr.Director

MBBS with MD Qualification is a must for this position

Minimum Post MD Exp required is 9 yrs

Experience in global drug development including US and/or Europe. Hands-on experience with clinical trial conduct in the United States and/or Europe. Able to coordinate filing of INDs/CTAs and participate in face to face meetings with the FDA and EMA (pre-IND, end of Phase I, II and III).

Ability to work in small team environment and to take a lead position in managing teams and projects. Ability to work on multiple active projects concurrently. High comfort level with working with geographically distant teams (both internal and CROs).

Mandatory:

• Documents for IND/CTA filings (IB, Protocol etc)

• Interaction with FDA/EMEA

• Exposure for interpretation of pre-clinical data

• Understanding of Registration path for Differentiated formulations

POSITION RESPONSIBILITIES:

List five to eight key responsibilities of the position

1. Be responsible for global clinical development of assigned differentiated formulation and NCE projects including:

a. Creation and updating of clinical development plan from project initiation to regulatory approval

b. Providing clinical input for multiple project teams

c. Serving as medical monitor for clinical trials both in India and elsewhere (Europe/North America) including:

i. Clinical trial design

ii. Protocol creation

iii. Site management

iv. Ongoing safety assessment

v. Clinical evaluation of data

vi. Clinical study report creation/finalization

d. Evaluating cumulative safety findings during clinical development

e. Serving as clinical lead for regulatory interactions

i. Face to face meetings with regulators including FDA/EMA

ii. Regulatory submissions (INDs, IND/CTA annual updates, PSURS, NDAs/CTAs etc.)

f. Annual Investigators Brochure updates

2. Supporting New Project Review (NPR) Team

a. Proposing new target therapeutic indications

b. Proposing molecules for new and differentiated formulations

c. Clinical assessment of proposed NPR targets

3. Mentoring peers in clinical/regulatory group

Location Hyderabad / Secunderabad

Contact

Sunil / R Varadarajan

Polaris Management services pvt ltd

2B, Sri Krishna Kaushikam,

2-2-647/287/12, Srinivasanagar Colony,

Baghamberpet

HYDERABAD -  500013

Email: polarisindia@gmail.com

Telephone 91-40-27403497

Posted under Hyderabad Jobs, Jobs By Category, Jobs by Location, Pharmaceuticals, Secunderabad Jobs

Leading Pharmaceutical Organization in India

Requires

Regulatory Affairs Proprietary Products – Director or Sr Director

M.Pharm /Ph.D. in Clinical Pharmacology / Pharmaceutics/MBBS/MD

WORK EXPERIENCE

About 10 years in Clinical Research, Regulatory Affairs, Compliance. Well versed with local (India) and international regulatory requirements.

POSITION RESPONSIBILITIES

1 Regulatory support to the PP team during portfolio identification with key inputs on regulatory simplicity/complexity on the said portfolio – makes Go/No Go decision from regulatory perspective.

2 Derive regulatory strategy (ies)/path to initiate Research and Development (R&D).

3 Enrich Clinical protocols with Regulatory acceptability – local (India) and international regulatory requirements.

4 Collaborate/work with Regulatory Agency(ies)/Consultants to derive/endorse key regulatory/clinical strategy(ies) – During R&D, pre- dossier submission, post-dossier submission

5 Review, compilation and submission of dossiers.

6 Collaborate and drive regulatory approvals with the local (India) and international regulatory body(ies).

7 Management of team, identification/retention of talents.

8 Knowledge sharing through Training and Development thus building repository of regulatory information.

9 Representation in National and International scientific/regulatory fraternity thus being the part of policy making/setting guidelines with the academic/professional body(ies)/regulatory body(ies)

Location: Hyderabad / Secunderabad

Contact

Madhavi /R Varadarajan

Polaris Management services pvt ltd

2B, Sri Krishna Kaushikam, 2-2-647/287/12,

Srinivasanagar Colony, Baghamberpet

HYDERABAD – 500013

Email: polarisindia@gmail.com

Tel: 40-27403495

Posted under Hyderabad Jobs, Jobs By Category, Jobs by Location, Pharmaceuticals, Secunderabad Jobs

A leading Retail store in Hyderabad

Requires

Business Development Manager

For 20000 sq ft of Retail Store (6 months into its operations) by the name of “Wishes and Dreams” and it houses all Gift, Home Décor, Crockery, Toys, Stationery, Cosmetics, Etc.

The candidate should understand the science of retailing (Pricing, Publicity, Marketing, Footfalls, conversion, Area Logistics, Loyalty Programme, Competition, Product Placement and Innovation)

Experience: 8 – 13 Years

Location: Hyderabad / Secunderabad

Compensation: Rupees 2,00,000 – 3,75,000/-

Contact

Ashwini / R Varadarajan

Polaris Management services pvt ltd

2B, Sri Krishna Kaushikam,

2-2-647/287/12, Srinivasanagar Colony,

Baghamberpet

HYDERABAD -  500013

Email: polarisindia@gmail.com

Telephone 040-27403495

Posted under Hyderabad Jobs, Jobs By Category, Jobs by Location, Sales, Marketing Jobs, Secunderabad Jobs